Trial Outcomes & Findings for Pilot Trial: Postoperative Opioid-free Analgesia (NCT NCT04254679)
NCT ID: NCT04254679
Last Updated: 2024-11-20
Results Overview
At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
81 participants
Primary outcome timeframe
4 months
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
Opioid Analgesia
Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Opioid-free Analgesia
Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Opioid Analgesia
Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Opioid-free Analgesia
Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Excluded owing to intraoperative complication requiring hospital stay
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Opioid Analgesia
n=39 Participants
Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Opioid-free Analgesia
n=37 Participants
Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 15.1 • n=39 Participants
|
56.8 years
STANDARD_DEVIATION 14 • n=37 Participants
|
55.5 years
STANDARD_DEVIATION 14.5 • n=76 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
26 Participants
n=37 Participants
|
50 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
11 Participants
n=37 Participants
|
26 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
39 participants
n=39 Participants
|
37 participants
n=37 Participants
|
76 participants
n=76 Participants
|
|
BMI
|
26.4 kg/m2
STANDARD_DEVIATION 4.7 • n=39 Participants
|
28.8 kg/m2
STANDARD_DEVIATION 8.7 • n=37 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 7 • n=76 Participants
|
|
BMI >= 30.0
|
7 Participants
n=39 Participants
|
11 Participants
n=37 Participants
|
18 Participants
n=76 Participants
|
|
American Society of Anesthesiology score I
|
6 Participants
n=39 Participants
|
9 Participants
n=37 Participants
|
15 Participants
n=76 Participants
|
|
American Society of Anesthesiology score II
|
25 Participants
n=39 Participants
|
28 Participants
n=37 Participants
|
53 Participants
n=76 Participants
|
|
American Society of Anesthesiology score III
|
2 Participants
n=39 Participants
|
6 Participants
n=37 Participants
|
8 Participants
n=76 Participants
|
|
Risk of opioid abuse score (SD)
|
2 units on a scale
STANDARD_DEVIATION 1.6 • n=39 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.7 • n=37 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.6 • n=76 Participants
|
|
Risk of opioid abuse score ≥4
|
4 Participants
n=39 Participants
|
5 Participants
n=37 Participants
|
9 Participants
n=76 Participants
|
|
Pain catastrophizing score, mean (SD)
|
13.5 units on a scale
STANDARD_DEVIATION 10.7 • n=39 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 11 • n=37 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 10.7 • n=76 Participants
|
|
Employed, including self-employed
|
24 Participants
n=39 Participants
|
20 Participants
n=37 Participants
|
44 Participants
n=76 Participants
|
|
Retired
|
9 Participants
n=39 Participants
|
11 Participants
n=37 Participants
|
20 Participants
n=76 Participants
|
|
Homemaker
|
2 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=76 Participants
|
|
Student
|
0 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Unemployed
|
1 Participants
n=39 Participants
|
4 Participants
n=37 Participants
|
5 Participants
n=76 Participants
|
|
Unable to work, receiving disability pension
|
3 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
4 Participants
n=76 Participants
|
|
Current smoker
|
8 Participants
n=39 Participants
|
5 Participants
n=37 Participants
|
13 Participants
n=76 Participants
|
|
Prerandomization treatment group preference: Unsure or no preference
|
13 Participants
n=39 Participants
|
15 Participants
n=37 Participants
|
28 Participants
n=76 Participants
|
|
Prerandomization treatment group preference: Opioid medication group
|
7 Participants
n=39 Participants
|
4 Participants
n=37 Participants
|
11 Participants
n=76 Participants
|
|
Prerandomization treatment group preference: Opioid-free medication group
|
19 Participants
n=39 Participants
|
18 Participants
n=37 Participants
|
37 Participants
n=76 Participants
|
|
Prerandomization perceptions of opioid-free analgesia: Very Effective
|
8 Participants
n=39 Participants
|
15 Participants
n=37 Participants
|
23 Participants
n=76 Participants
|
|
Prerandomization perceptions of opioid-free analgesia: Somewhat Effective
|
17 Participants
n=39 Participants
|
11 Participants
n=37 Participants
|
28 Participants
n=76 Participants
|
|
Prerandomization perceptions of opioid-free analgesia: Not effective
|
0 Participants
n=39 Participants
|
2 Participants
n=37 Participants
|
2 Participants
n=76 Participants
|
|
Prerandomization perceptions of opioid-free analgesia: No specific expectation
|
14 Participants
n=39 Participants
|
9 Participants
n=37 Participants
|
23 Participants
n=76 Participants
|
|
Abdominal Surgery
|
20 Participants
n=39 Participants
|
20 Participants
n=37 Participants
|
40 Participants
n=76 Participants
|
|
Laparoscopic appendectomy
|
0 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Laparoscopic cholecystectomy
|
3 Participants
n=39 Participants
|
6 Participants
n=37 Participants
|
9 Participants
n=76 Participants
|
|
Laparoscopic inguinal hernia repair
|
8 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
9 Participants
n=76 Participants
|
|
Open inguinal hernia repair
|
8 Participants
n=39 Participants
|
9 Participants
n=37 Participants
|
17 Participants
n=76 Participants
|
|
Open umbilical hernia repair
|
1 Participants
n=39 Participants
|
2 Participants
n=37 Participants
|
3 Participants
n=76 Participants
|
|
Open incisional hernia repair
|
0 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Breast surgery
|
19 Participants
n=39 Participants
|
17 Participants
n=37 Participants
|
36 Participants
n=76 Participants
|
|
Partial mastectomy
|
4 Participants
n=39 Participants
|
10 Participants
n=37 Participants
|
14 Participants
n=76 Participants
|
|
Partial mastectomy with sentinel node biopsy
|
7 Participants
n=39 Participants
|
4 Participants
n=37 Participants
|
11 Participants
n=76 Participants
|
|
Partial mastectomy with axillary node dissection
|
4 Participants
n=39 Participants
|
2 Participants
n=37 Participants
|
6 Participants
n=76 Participants
|
|
Partial mastectomy with sentinel node biopsy and reconstruction
|
0 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Total mastectomy with sentinel node biopsy
|
2 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=76 Participants
|
|
Total mastectomy with sentinel node biopsy and reconstruction
|
1 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Total mastectomy with axillary node dissection and reconstruction
|
1 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=76 Participants
|
|
Received intraoperative regional analgesia
|
31 Participants
n=39 Participants
|
26 Participants
n=37 Participants
|
57 Participants
n=76 Participants
|
|
Peripheral nerve block
|
5 Participants
n=39 Participants
|
6 Participants
n=37 Participants
|
11 Participants
n=76 Participants
|
|
Wound infiltration
|
31 Participants
n=39 Participants
|
26 Participants
n=37 Participants
|
57 Participants
n=76 Participants
|
|
Duration of surgery
|
97 min
STANDARD_DEVIATION 39 • n=39 Participants
|
84 min
STANDARD_DEVIATION 51 • n=37 Participants
|
91 min
STANDARD_DEVIATION 45 • n=76 Participants
|
|
Amount of opioids received in the PACU
|
18 MME
STANDARD_DEVIATION 14 • n=39 Participants
|
25 MME
STANDARD_DEVIATION 21 • n=37 Participants
|
21 MME
STANDARD_DEVIATION 18 • n=76 Participants
|
PRIMARY outcome
Timeframe: 4 monthsAt least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Outcome measures
| Measure |
Total Number of Screened Patients
n=224 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Screened Participants Who Were Eligible to Participate in the Study
|
163 Participants
|
—
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: \*Providers were not considered as enrolled participants but did contribute to this assessment.
At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).
Outcome measures
| Measure |
Total Number of Screened Patients
n=15 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: 4 monthsAt least 50% of eligible patients agree to participate in the study and are randomized.
Outcome measures
| Measure |
Total Number of Screened Patients
n=168 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Eligible Patients Agreeing to Participate
|
93 Participants
|
—
|
PRIMARY outcome
Timeframe: 4 monthsAt least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Randomized Patients Complying With Allocated Treatment
|
39 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 4 monthsAt least 80% of the randomized patients complete outcome assessment at 30 days after surgery.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
|
39 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample.
Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.
Outcome measures
| Measure |
Total Number of Screened Patients
n=3724 Questionnaires
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
|
37 Questionnaires
|
—
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample.
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).
Outcome measures
| Measure |
Total Number of Screened Patients
n=32256 Questionnaire Items
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
|
33 Questionnaire Items
|
—
|
SECONDARY outcome
Timeframe: 30 days.Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Postoperative Pain
Baseline Severity Scale score
|
0.9 score on a scale
Standard Deviation 1.7
|
1 score on a scale
Standard Deviation 2
|
|
Postoperative Pain
Post Operative Day (POD) 1 Severity Scale score
|
2.8 score on a scale
Standard Deviation 2.2
|
3 score on a scale
Standard Deviation 1.7
|
|
Postoperative Pain
POD2 Severity Scale score
|
2.7 score on a scale
Standard Deviation 2.3
|
2.6 score on a scale
Standard Deviation 2.1
|
|
Postoperative Pain
POD3 Severity Scale score
|
2.1 score on a scale
Standard Deviation 2
|
1.7 score on a scale
Standard Deviation 1.8
|
|
Postoperative Pain
POD4 Severity Scale score
|
1.6 score on a scale
Standard Deviation 1.7
|
1.4 score on a scale
Standard Deviation 1.7
|
|
Postoperative Pain
POD5 Severity Scale score
|
1.3 score on a scale
Standard Deviation 1.7
|
1.1 score on a scale
Standard Deviation 1.3
|
|
Postoperative Pain
POD6 Severity Scale score
|
1.2 score on a scale
Standard Deviation 1.5
|
1.1 score on a scale
Standard Deviation 1.4
|
|
Postoperative Pain
POD7 Severity Scale score
|
1.1 score on a scale
Standard Deviation 1.6
|
0.9 score on a scale
Standard Deviation 1.2
|
|
Postoperative Pain
Post Operative Week (POW) 2 Severity Scale score
|
0.9 score on a scale
Standard Deviation 1.4
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Postoperative Pain
POW3 Severity Scale score
|
0.5 score on a scale
Standard Deviation 1
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Postoperative Pain
POW4 Severity Scale score
|
0.5 score on a scale
Standard Deviation 1.3
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Postoperative Pain
Baseline Interference Scale score
|
0.9 score on a scale
Standard Deviation 1.9
|
0.7 score on a scale
Standard Deviation 1.7
|
|
Postoperative Pain
POD 1 Interference Scale score
|
3 score on a scale
Standard Deviation 3.1
|
3.3 score on a scale
Standard Deviation 2.1
|
|
Postoperative Pain
POD 2 Interference Scale score
|
2.4 score on a scale
Standard Deviation 2.5
|
2.3 score on a scale
Standard Deviation 2
|
|
Postoperative Pain
POD 3 Interference Scale score
|
1.9 score on a scale
Standard Deviation 2.5
|
1.8 score on a scale
Standard Deviation 1.9
|
|
Postoperative Pain
POD 4 Interference Scale score
|
1.6 score on a scale
Standard Deviation 2.6
|
1.4 score on a scale
Standard Deviation 1.9
|
|
Postoperative Pain
POD 5 Interference Scale score
|
1.1 score on a scale
Standard Deviation 1.9
|
1 score on a scale
Standard Deviation 1.7
|
|
Postoperative Pain
POD 6 Interference Scale score
|
1.2 score on a scale
Standard Deviation 2
|
0.8 score on a scale
Standard Deviation 1.5
|
|
Postoperative Pain
POD 7 Interference Scale score
|
1.1 score on a scale
Standard Deviation 2
|
1 score on a scale
Standard Deviation 1.9
|
|
Postoperative Pain
POW 2 Interference Scale score
|
1 score on a scale
Standard Deviation 1.7
|
0.5 score on a scale
Standard Deviation 1.5
|
|
Postoperative Pain
POW 3 Interference Scale score
|
0.6 score on a scale
Standard Deviation 1.5
|
0.4 score on a scale
Standard Deviation 1.2
|
|
Postoperative Pain
POW 4 Interference Scale score
|
0.2 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 30 days.The time to the first report of stopping the use of pain medication.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Time to Stopping Pain Medication
|
9 days postoperative
Standard Deviation 9
|
9 days postoperative
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 after surgery.Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Postoperative Health Status
Physical functioning Baseline
|
50.2 T-score
Standard Deviation 8.3
|
50.8 T-score
Standard Deviation 8.6
|
|
Postoperative Health Status
Physical functioning Post Operative Week (POW) 1
|
44.9 T-score
Standard Deviation 8.3
|
44.1 T-score
Standard Deviation 9.1
|
|
Postoperative Health Status
Social participation POW 2
|
54.5 T-score
Standard Deviation 8.8
|
54.4 T-score
Standard Deviation 8.3
|
|
Postoperative Health Status
Anxiety Baseline
|
53.3 T-score
Standard Deviation 9.9
|
53 T-score
Standard Deviation 8.5
|
|
Postoperative Health Status
Anxiety POW 1
|
46.4 T-score
Standard Deviation 8.4
|
48.6 T-score
Standard Deviation 8
|
|
Postoperative Health Status
Anxiety POW 2
|
45.9 T-score
Standard Deviation 8.1
|
44.7 T-score
Standard Deviation 6.9
|
|
Postoperative Health Status
Anxiety POW 4
|
44.5 T-score
Standard Deviation 6.7
|
44.4 T-score
Standard Deviation 6.7
|
|
Postoperative Health Status
Depression Baseline
|
47.1 T-score
Standard Deviation 8.7
|
48 T-score
Standard Deviation 8.2
|
|
Postoperative Health Status
Depression POW 3
|
44.7 T-score
Standard Deviation 6.4
|
43.7 T-score
Standard Deviation 5
|
|
Postoperative Health Status
Depression POW 4
|
44.1 T-score
Standard Deviation 5.3
|
44.3 T-score
Standard Deviation 6
|
|
Postoperative Health Status
Pain interference Baseline
|
49.1 T-score
Standard Deviation 9
|
48.4 T-score
Standard Deviation 8.9
|
|
Postoperative Health Status
Pain interference POW 1
|
55.7 T-score
Standard Deviation 8.3
|
55.5 T-score
Standard Deviation 9.1
|
|
Postoperative Health Status
Pain interference POW 2
|
50.5 T-score
Standard Deviation 8.9
|
49.9 T-score
Standard Deviation 7.1
|
|
Postoperative Health Status
POW 3
|
48.5 T-score
Standard Deviation 7.6
|
46.5 T-score
Standard Deviation 7.3
|
|
Postoperative Health Status
POW 4
|
45.9 T-score
Standard Deviation 6.8
|
46.7 T-score
Standard Deviation 7.1
|
|
Postoperative Health Status
Sleep disturbance POW 1
|
47.1 T-score
Standard Deviation 8.5
|
47.4 T-score
Standard Deviation 9.1
|
|
Postoperative Health Status
Sleep disturbance POW 2
|
45.2 T-score
Standard Deviation 7.5
|
46.9 T-score
Standard Deviation 9
|
|
Postoperative Health Status
Fatigue Baseline
|
45.9 T-score
Standard Deviation 9.5
|
47.7 T-score
Standard Deviation 10
|
|
Postoperative Health Status
Fatigue POW 1
|
48.4 T-score
Standard Deviation 9.4
|
50.2 T-score
Standard Deviation 11.2
|
|
Postoperative Health Status
Social participation POW 4
|
57.2 T-score
Standard Deviation 8.4
|
56.6 T-score
Standard Deviation 8.4
|
|
Postoperative Health Status
Physical functioning POW 2
|
47.2 T-score
Standard Deviation 7.5
|
47.9 T-score
Standard Deviation 8.1
|
|
Postoperative Health Status
Physical functioning POW 3
|
49.6 T-score
Standard Deviation 7.7
|
50.6 T-score
Standard Deviation 7.3
|
|
Postoperative Health Status
Physical functioning POW 4
|
52.1 T-score
Standard Deviation 7
|
51.5 T-score
Standard Deviation 7.2
|
|
Postoperative Health Status
Social participation Baseline
|
55 T-score
Standard Deviation 9.4
|
52.9 T-score
Standard Deviation 8.7
|
|
Postoperative Health Status
Social participation POW 1
|
49.6 T-score
Standard Deviation 9.6
|
47.3 T-score
Standard Deviation 10.4
|
|
Postoperative Health Status
Social participation POW 3
|
56.5 T-score
Standard Deviation 8
|
55.6 T-score
Standard Deviation 8.6
|
|
Postoperative Health Status
Anxiety POW 3
|
44.4 T-score
Standard Deviation 6.4
|
43.2 T-score
Standard Deviation 5.6
|
|
Postoperative Health Status
Depression POW 1
|
45.6 T-score
Standard Deviation 6.8
|
46.2 T-score
Standard Deviation 7.2
|
|
Postoperative Health Status
Depression POW 2
|
45.1 T-score
Standard Deviation 6.7
|
43.6 T-score
Standard Deviation 5.8
|
|
Postoperative Health Status
Sleep disturbance Baseline
|
46.8 T-score
Standard Deviation 9.8
|
49.3 T-score
Standard Deviation 8.6
|
|
Postoperative Health Status
Sleep disturbance POW 3
|
45 T-score
Standard Deviation 8.3
|
46.1 T-score
Standard Deviation 9.3
|
|
Postoperative Health Status
Sleep disturbance POW 4
|
43.6 T-score
Standard Deviation 8.5
|
44.3 T-score
Standard Deviation 9.3
|
|
Postoperative Health Status
Fatigue POW 2
|
43 T-score
Standard Deviation 9.6
|
44.6 T-score
Standard Deviation 10.3
|
|
Postoperative Health Status
Fatigue POW 3
|
41.8 T-score
Standard Deviation 8.2
|
42.4 T-score
Standard Deviation 9.9
|
|
Postoperative Health Status
Fatigue POW 4
|
40.9 T-score
Standard Deviation 7.7
|
42.2 T-score
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Postoperative days 1 to 7, weeks 2, 3 and 4 after surgeryMeasured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. The reported rates indicate the number of reported events per period of evaluation.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Opioid Side-effects
Vomiting : 7-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Itching : 30-day rate (clinically meaningful event)
|
1 Number of reported events
|
2 Number of reported events
|
|
Opioid Side-effects
Fatigue : 7-day rate (clinically meaningful event)
|
2 Number of reported events
|
5 Number of reported events
|
|
Opioid Side-effects
Fatigue : 30-day rate (any event)
|
32 Number of reported events
|
30 Number of reported events
|
|
Opioid Side-effects
Fatigue : 30-day rate (clinically meaningful event)
|
3 Number of reported events
|
11 Number of reported events
|
|
Opioid Side-effects
Drowsiness : 30-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Dizziness : 30-day rate (any event)
|
8 Number of reported events
|
7 Number of reported events
|
|
Opioid Side-effects
Inability to concentrate : 7-day rate (any event)
|
6 Number of reported events
|
11 Number of reported events
|
|
Opioid Side-effects
Inability to concentrate : 7-day rate (clinically meaningful event)
|
1 Number of reported events
|
2 Number of reported events
|
|
Opioid Side-effects
Difficulty with urination : 30-day rate (clinically meaningful event)
|
1 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Confusion : 7-day rate (any event)
|
2 Number of reported events
|
3 Number of reported events
|
|
Opioid Side-effects
Confusion : 7-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Confusion : 30-day rate (any event)
|
2 Number of reported events
|
3 Number of reported events
|
|
Opioid Side-effects
Constipation : 7-day rate (any event)
|
16 Number of reported events
|
12 Number of reported events
|
|
Opioid Side-effects
Constipation : 7-day rate (clinically meaningful event)
|
4 Number of reported events
|
2 Number of reported events
|
|
Opioid Side-effects
Constipation : 30-day rate (any event)
|
18 Number of reported events
|
15 Number of reported events
|
|
Opioid Side-effects
Constipation : 30-day rate (clinically meaningful event)
|
7 Number of reported events
|
3 Number of reported events
|
|
Opioid Side-effects
Nausa : 7-day rate (any event)
|
8 Number of reported events
|
6 Number of reported events
|
|
Opioid Side-effects
Nausa : 7-day rate (clinically meaningful event)
|
1 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Nausa : 30-day rate (any event)
|
9 Number of reported events
|
8 Number of reported events
|
|
Opioid Side-effects
Nausa : 30-day rate (clinically meaningful event)
|
1 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Vomiting : 7-day rate (any event)
|
3 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Vomiting : 30-day rate (any event)
|
6 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Vomiting : 30-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Itching : 7-day rate (any event)
|
13 Number of reported events
|
7 Number of reported events
|
|
Opioid Side-effects
Itching : 7-day rate (clinically meaningful event)
|
1 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Itching : 30-day rate (any event)
|
15 Number of reported events
|
15 Number of reported events
|
|
Opioid Side-effects
Fatigue : 7-day rate (any event)
|
31 Number of reported events
|
28 Number of reported events
|
|
Opioid Side-effects
Drowsiness : 7-day rate (any event)
|
14 Number of reported events
|
13 Number of reported events
|
|
Opioid Side-effects
Drowsiness : 7-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Drowsiness : 30-day rate (any event)
|
14 Number of reported events
|
13 Number of reported events
|
|
Opioid Side-effects
Dizziness : 7-day rate (any event)
|
7 Number of reported events
|
6 Number of reported events
|
|
Opioid Side-effects
Dizziness : 7-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Dizziness : 30-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Inability to concentrate : 30-day rate (any event)
|
8 Number of reported events
|
11 Number of reported events
|
|
Opioid Side-effects
Inability to concentrate : 30-day rate (clinically meaningful event)
|
1 Number of reported events
|
2 Number of reported events
|
|
Opioid Side-effects
Difficulty with urination : 7-day rate (any event)
|
3 Number of reported events
|
3 Number of reported events
|
|
Opioid Side-effects
Difficulty with urination : 7-day rate (clinically meaningful event)
|
1 Number of reported events
|
1 Number of reported events
|
|
Opioid Side-effects
Difficulty with urination : 30-day rate (any event)
|
4 Number of reported events
|
4 Number of reported events
|
|
Opioid Side-effects
Confusion : 30-day rate (clinically meaningful event)
|
0 Number of reported events
|
1 Number of reported events
|
SECONDARY outcome
Timeframe: 4 weeksMeasured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to \>1 question indicates the patient exhibits prescription opioid misuse.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Rate of Opioid Misuse
|
0.1 score on a scale
Standard Deviation 0.4
|
0.1 score on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 30 days.Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse). Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Postoperative Complications Classification
I
|
3 Participants
|
1 Participants
|
|
Postoperative Complications Classification
II
|
2 Participants
|
0 Participants
|
|
Postoperative Complications Classification
IIIa/b
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days.Emergency department visits, hospital readmissions.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Rate of Unplanned Healthcare Utilization
Any
|
6 Participants
|
1 Participants
|
|
Rate of Unplanned Healthcare Utilization
ED visit
|
5 Participants
|
0 Participants
|
|
Rate of Unplanned Healthcare Utilization
Readmission
|
1 Participants
|
1 Participants
|
|
Rate of Unplanned Healthcare Utilization
Outpatient clinic visit
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after surgeryObtained from spontaneous patient reporting (Trigger question "Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?"). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Rate of Adverse Drug Events
Abdominal distention
|
0 Participants
|
3 Participants
|
|
Rate of Adverse Drug Events
Diarrhea
|
1 Participants
|
2 Participants
|
|
Rate of Adverse Drug Events
Postoperative wound infection
|
2 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Cough
|
1 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Urinary retention
|
1 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Breast haematoma
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Productive cough
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Dyspepsia
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Ecchymosis
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Hypoesthesia
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Seroma
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Cystitis
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Peripheral neuropathy
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Headache
|
4 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Hypertention
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Tachycardia
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Neuralgia
|
1 Participants
|
0 Participants
|
|
Rate of Adverse Drug Events
Oropharyngeal pain
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Penile swelling
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Testicular swelling
|
0 Participants
|
1 Participants
|
|
Rate of Adverse Drug Events
Urinary tract infection
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsFilling of opioid prescriptions up to 3 months after surgery.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Rate of Prolonged Opioid Use
Post Operative Week (POW) 1
|
25 Participants
|
1 Participants
|
|
Rate of Prolonged Opioid Use
POW 2
|
0 Participants
|
0 Participants
|
|
Rate of Prolonged Opioid Use
POW 3
|
0 Participants
|
0 Participants
|
|
Rate of Prolonged Opioid Use
POW 4
|
0 Participants
|
0 Participants
|
|
Rate of Prolonged Opioid Use
POM 2
|
0 Participants
|
1 Participants
|
|
Rate of Prolonged Opioid Use
POM 3
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysMeasured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications.
Outcome measures
| Measure |
Total Number of Screened Patients
n=39 Participants
Total number of patients undergoing outpatient general surgery procedures.
|
Opioid-free Analgesia
n=37 Participants
The total number of patients included in the opioid-free analgesia arm
|
|---|---|---|
|
Comprehensive Complication Index at 30-day
|
2.6 score on a scale
Standard Deviation 7.2
|
0.9 score on a scale
Standard Deviation 4.5
|
Adverse Events
Opioid Analgesia
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Opioid-free Analgesia
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid Analgesia
n=39 participants at risk
Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Opioid-free Analgesia
n=37 participants at risk
Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
|---|---|---|
|
Surgical and medical procedures
Breast Haematoma
|
2.6%
1/39 • Number of events 1 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
0.00%
0/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
Surgical and medical procedures
Seroma
|
0.00%
0/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
2.7%
1/37 • Number of events 1 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
Other adverse events
| Measure |
Opioid Analgesia
n=39 participants at risk
Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
Opioid-free Analgesia
n=37 participants at risk
Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
|
|---|---|---|
|
General disorders
Headache
|
10.3%
4/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
2.7%
1/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
Surgical and medical procedures
Abdominal distention
|
0.00%
0/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
8.1%
3/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
5.4%
2/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
Surgical and medical procedures
Postoperative wound infection
|
5.1%
2/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
0.00%
0/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
Gastrointestinal disorders
Constipation
|
17.9%
7/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
8.1%
3/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
General disorders
Itching
|
2.6%
1/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
5.4%
2/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
General disorders
Fatigue
|
7.7%
3/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
29.7%
11/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
|
General disorders
Inability to concentrate
|
2.6%
1/39 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
5.4%
2/37 • The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place