Trial Outcomes & Findings for Perioperative Pain Management In Spine Surgery Patients: Part I (NCT NCT01447888)
NCT ID: NCT01447888
Last Updated: 2020-04-27
Results Overview
We will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.
COMPLETED
NA
100 participants
4 hours post surgery
2020-04-27
Participant Flow
Participant milestones
| Measure |
150% Oral Morphine Equivalent (OME)
Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients
150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
|
Control
Standard perioperative dosing, which does not currently account for patients' baseline opiate use.
Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
55
|
|
Overall Study
COMPLETED
|
45
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
150% Oral Morphine Equivalent (OME)
n=45 Participants
Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients
150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
|
Control
n=55 Participants
Standard perioperative dosing, which does not currently account for patients' baseline opiate use.
Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11.7 • n=45 Participants
|
52 years
STANDARD_DEVIATION 12.6 • n=55 Participants
|
51.55 years
STANDARD_DEVIATION 12.15 • n=100 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=45 Participants
|
32 Participants
n=55 Participants
|
47 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=45 Participants
|
23 Participants
n=55 Participants
|
53 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
45 participants
n=45 Participants
|
55 participants
n=55 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 4 hours post surgeryWe will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.
Outcome measures
| Measure |
150% Oral Morphine Equivalent (OME)
n=45 Participants
Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients
150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
|
Control
n=55 Participants
Standard perioperative dosing, which does not currently account for patients' baseline opiate use.
Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
|
|---|---|---|
|
Immediate Postoperative Pain Control
|
6.6 score on a scale
Standard Deviation 2.1
|
6.8 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 24 hours after the recovery periodWe will be assessing if the intervention improved postoperative pain management during the first 24 hours after the recovery period (first 4 hours postoperatively) as compared to the non-intervention group. Measures that will be used to assess success: Verbal pain scores, opioid consumption (doses and frequency), and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.
Outcome measures
| Measure |
150% Oral Morphine Equivalent (OME)
n=45 Participants
Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients
150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
|
Control
n=55 Participants
Standard perioperative dosing, which does not currently account for patients' baseline opiate use.
Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
|
|---|---|---|
|
Pain Management Improvement at 24 Hours After the Recovery Period
|
5.8 score on a scale
Standard Deviation 2.0
|
6.4 score on a scale
Standard Deviation 1.6
|
Adverse Events
150% Oral Morphine Equivalent (OME)
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place