Trial Outcomes & Findings for Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients (NCT NCT05900427)
NCT ID: NCT05900427
Last Updated: 2026-08-06
Results Overview
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) Postoperative Day 1 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
TERMINATED
PHASE4
78 participants
on Postoperative Day 1
2026-08-06
Participant Flow
This trial enrolled patients within the Endeavor Health Orthopedic and Spine Institute between October 2023 and October 2025. All participants provided written informed consent prior to their participation in the study via an electronic consent form in REDCap. Informed consent was obtained after receiving permission from the orthopedic surgery team to recruit the patient, followed by a discussion of the study and consent form with research staff via telephone.
Seven patients were withdrawn from the study following enrollment but prior to study group assignment. Of these seven patients, five were withdrawn due to rescheduled or cancelled procedures and two were withdrawn due to weighing \<60 kg on the day of surgery.
Participant milestones
| Measure |
Liposomal Bupivacaine Group
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine Group
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Group
n=34 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 Years
STANDARD_DEVIATION 9 • n=34 Participants
|
71 Years
STANDARD_DEVIATION 7 • n=33 Participants
|
70 Years
STANDARD_DEVIATION 8 • n=67 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=34 Participants
|
14 Participants
n=33 Participants
|
32 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=34 Participants
|
19 Participants
n=33 Participants
|
35 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
30 Participants
n=34 Participants
|
32 Participants
n=33 Participants
|
62 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Race · Other/unknown
|
4 Participants
n=34 Participants
|
1 Participants
n=33 Participants
|
5 Participants
n=67 Participants
|
|
ASA Status
2
|
17 Participants
n=34 Participants
|
14 Participants
n=33 Participants
|
31 Participants
n=67 Participants
|
|
ASA Status
3
|
17 Participants
n=34 Participants
|
19 Participants
n=33 Participants
|
36 Participants
n=67 Participants
|
|
Height
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=34 Participants
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=33 Participants
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=67 Participants
|
|
Weight
|
81.2 Kilograms
STANDARD_DEVIATION 14.2 • n=34 Participants
|
87.8 Kilograms
STANDARD_DEVIATION 83.9 • n=33 Participants
|
84.5 Kilograms
STANDARD_DEVIATION 16.2 • n=67 Participants
|
|
BMI
BMI
|
28.3 Kg/m^2
STANDARD_DEVIATION 5.6 • n=34 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
30.3 Kg/m^2
STANDARD_DEVIATION 4.3 • n=33 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
29.2 Kg/m^2
STANDARD_DEVIATION 5.1 • n=67 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
|
BMI
BMI of Female Subjects
|
29.5 Kg/m^2
STANDARD_DEVIATION 6.8 • n=18 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
31.6 Kg/m^2
STANDARD_DEVIATION 4.9 • n=14 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
30.4 Kg/m^2
STANDARD_DEVIATION 6.1 • n=32 Participants • Mean BMI was reported for all subjects (N = 67). Mean BMI for only female subjects was also reported separately (N = 32).
|
|
Alcohol Use (yes)
|
7 Participants
n=34 Participants
|
8 Participants
n=33 Participants
|
15 Participants
n=67 Participants
|
|
Cannabis Use (yes)
|
1 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=67 Participants
|
|
Tobacco Use (yes)
|
9 Participants
n=34 Participants
|
11 Participants
n=33 Participants
|
20 Participants
n=67 Participants
|
|
System Comorbidities
Liver (yes)
|
0 Participants
n=34 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=67 Participants
|
|
System Comorbidities
Kidney (yes)
|
3 Participants
n=34 Participants
|
1 Participants
n=33 Participants
|
4 Participants
n=67 Participants
|
|
System Comorbidities
Endocrine (yes)
|
5 Participants
n=34 Participants
|
10 Participants
n=33 Participants
|
15 Participants
n=67 Participants
|
|
System Comorbidities
Respiratory (yes)
|
14 Participants
n=34 Participants
|
16 Participants
n=33 Participants
|
30 Participants
n=67 Participants
|
|
Hospital Length of Stay
|
18.0 Hours
STANDARD_DEVIATION 11.6 • n=34 Participants
|
19.2 Hours
STANDARD_DEVIATION 13.6 • n=33 Participants
|
18.6 Hours
STANDARD_DEVIATION 12.5 • n=67 Participants
|
|
System Comorbidities
Neurologic (yes)
|
3 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=67 Participants
|
|
Medical History
Taking Prescription Medications (yes)
|
33 Participants
n=34 Participants
|
32 Participants
n=33 Participants
|
65 Participants
n=67 Participants
|
|
Medical History
History of Prior Surgery (yes)
|
33 Participants
n=34 Participants
|
31 Participants
n=33 Participants
|
64 Participants
n=67 Participants
|
|
Procedure Type
Reverse Total Shoulder Arthroplasty
|
25 Participants
n=34 Participants
|
27 Participants
n=33 Participants
|
52 Participants
n=67 Participants
|
|
Procedure Type
Primary Total Shoulder Arthroplasty
|
9 Participants
n=34 Participants
|
6 Participants
n=33 Participants
|
15 Participants
n=67 Participants
|
|
BMI
|
27.0 Kg/m^2
n=34 Participants
|
30.0 Kg/m^2
n=33 Participants
|
28.3 Kg/m^2
n=67 Participants
|
|
Procedure Duration
|
1.6 Hours
STANDARD_DEVIATION 0.5 • n=34 Participants
|
1.6 Hours
STANDARD_DEVIATION 0.5 • n=33 Participants
|
1.6 Hours
STANDARD_DEVIATION 0.5 • n=67 Participants
|
|
Surgery Duration
|
2.7 Hours
STANDARD_DEVIATION 0.7 • n=34 Participants
|
2.7 Hours
STANDARD_DEVIATION 0.7 • n=33 Participants
|
2.7 Hours
STANDARD_DEVIATION 0.7 • n=67 Participants
|
|
Surgical Complications (yes)
|
0 Participants
n=34 Participants
|
2 Participants
n=33 Participants
|
2 Participants
n=67 Participants
|
|
Surgery Type
Hospital Admission
|
14 Participants
n=34 Participants
|
12 Participants
n=33 Participants
|
26 Participants
n=67 Participants
|
|
Surgery Type
Outpatient
|
20 Participants
n=34 Participants
|
21 Participants
n=33 Participants
|
41 Participants
n=67 Participants
|
|
Last Hospital VAS Pain Score
|
1.8 score on a scale
STANDARD_DEVIATION 2.0 • n=34 Participants • Visual Analogue Scale (VAS) is a validated, 10-cm horizontal line used to measure subjective pain or symptom intensity, ranging from "no pain" (0) to "worst pain" (10)
|
2.2 score on a scale
STANDARD_DEVIATION 2.4 • n=33 Participants • Visual Analogue Scale (VAS) is a validated, 10-cm horizontal line used to measure subjective pain or symptom intensity, ranging from "no pain" (0) to "worst pain" (10)
|
2.0 score on a scale
STANDARD_DEVIATION 2.2 • n=67 Participants • Visual Analogue Scale (VAS) is a validated, 10-cm horizontal line used to measure subjective pain or symptom intensity, ranging from "no pain" (0) to "worst pain" (10)
|
PRIMARY outcome
Timeframe: on Postoperative Day 1Population: 3 participants in the Liposomal Bupivacaine group were lost to follow up for the primary outcome.
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) Postoperative Day 1 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Clinically Tolerable (VAS ≤ 4)
|
12 Participants
|
8 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Clinically Intolerable (VAS > 4)
|
19 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: on PACU admission, PACU discharge, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5Population: In the liposomal bupivacaine group, 2 subjects were lost to follow up on postoperative days 2, 4, and 5, and 3 subjects were lost to follow up on postoperative day 3. In the plain bupivacaine group, 1 subject was lost to follow up on postoperative days 2 and 4, and 2 subjects were lost to follow up on postoperative days 3 and 5.
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) at PACU admission, PACU discharge, and on postoperative days 2, 3, 4, and 5 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=33 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=34 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
PACU Admission · Clinically Tolerable (VAS ≤ 4)
|
31 Participants
|
32 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
PACU Admission · Clinically Intolerable (VAS > 4)
|
2 Participants
|
2 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
PACU Discharge · Clinically Tolerable (VAS ≤ 4)
|
29 Participants
|
32 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
PACU Discharge · Clinically Intolerable (VAS > 4)
|
4 Participants
|
2 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 2 · Clinically Tolerable (VAS ≤ 4)
|
9 Participants
|
12 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 2 · Clinically Intolerable (VAS > 4)
|
23 Participants
|
20 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 3 · Clinically Tolerable (VAS ≤ 4)
|
18 Participants
|
13 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 3 · Clinically Intolerable (VAS > 4)
|
13 Participants
|
18 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 4 · Clinically Tolerable (VAS ≤ 4)
|
20 Participants
|
16 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 4 · Clinically Intolerable (VAS > 4)
|
12 Participants
|
16 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 5 · Clinically Tolerable (VAS ≤ 4)
|
23 Participants
|
18 Participants
|
|
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Postoperative Day 5 · Clinically Intolerable (VAS > 4)
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Upon Post Anesthesia Care Unit (PACU) Admission; PACU Discharge, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.Population: In the liposomal bupivacaine group, 2 subjects were lost to follow up on postoperative days 2, 4, and 5, and 3 subjects were lost to follow up on postoperative days 1 and 3. In the plain bupivacaine group, 1 subject was lost to follow up on postoperative days 2 and 4, and 2 subjects were lost to follow up on postoperative days 3 and 5.
The investigators will collect the difference in VAS pain scores (0 - 10) in each group. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=34 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Postoperative Day 3
|
4.7 scored on a scale
Interval 2.5 to 6.7
|
4 scored on a scale
Interval 2.9 to 5.0
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Postoperative Day 4
|
4.1 scored on a scale
Interval 1.9 to 6.0
|
3.3 scored on a scale
Interval 1.8 to 5.0
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
PACU Admission
|
0 scored on a scale
Interval 0.0 to 0.0
|
0 scored on a scale
Interval 0.0 to 0.0
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
PACU Discharge
|
0 scored on a scale
Interval 0.0 to 2.0
|
0 scored on a scale
Interval 0.0 to 2.0
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Postoperative Day 1
|
5 scored on a scale
Interval 3.2 to 6.9
|
6.4 scored on a scale
Interval 4.1 to 7.4
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Postoperative Day 2
|
5.1 scored on a scale
Interval 3.7 to 7.1
|
5 scored on a scale
Interval 3.6 to 6.6
|
|
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Postoperative Day 5
|
3.7 scored on a scale
Interval 1.3 to 5.1
|
3 scored on a scale
Interval 1.4 to 4.1
|
SECONDARY outcome
Timeframe: At baseline (before surgery) and on Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.Population: Subjects who did not complete all 15 questions were considered lost to follow up and excluded from analysis. In the liposomal bupivacaine, the following subjects were lost to follow up: Baseline: 3 , Day 1: 2, Day 2: 5, Day 3: 5, Day 4: 5, Day 5: 3. In the plain bupivacaine group, the following subjects were lost to follow up: Baseline: 4, Day 1: 2, Day 2: 4, Day 3: 4, Day 4: 3, Day 5: 3.
The investigators will collect the difference in quality of recovery survey-15 responses in each group. QoR15 survey has 15 questions each with a scale of 0-10. Number "0" indicates none of the time and number "10" indicates all of the time. Total scores are reported as a sum with the maximum score being 150. 136 - 150: Excellent recovery 122 - 135: Good recovery 90 - 121: Moderate recovery 0 - 89: Poor recovery respectively
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=34 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
The Difference in Quality of Recovery Survey-15 Responses
Baseline
|
122.3 score on a scale
Standard Deviation 18.8
|
122.3 score on a scale
Standard Deviation 14.7
|
|
The Difference in Quality of Recovery Survey-15 Responses
Postoperative Day 1
|
100.5 score on a scale
Standard Deviation 21.5
|
99.6 score on a scale
Standard Deviation 22.6
|
|
The Difference in Quality of Recovery Survey-15 Responses
Postoperative Day 2
|
107.4 score on a scale
Standard Deviation 18.7
|
110.4 score on a scale
Standard Deviation 18.3
|
|
The Difference in Quality of Recovery Survey-15 Responses
Postoperative Day 3
|
112.8 score on a scale
Standard Deviation 15.4
|
113.8 score on a scale
Standard Deviation 18.1
|
|
The Difference in Quality of Recovery Survey-15 Responses
Postoperative Day 4
|
116.2 score on a scale
Standard Deviation 18.9
|
115.5 score on a scale
Standard Deviation 20.1
|
|
The Difference in Quality of Recovery Survey-15 Responses
Postoperative Day 5
|
119.5 score on a scale
Standard Deviation 16
|
117.7 score on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: On the day of surgery in the PACU, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative and Day 5.Population: One subject in the liposomal bupivacaine group was lost to follow up for MME data.
The investigators will collect opioid use in morphine milligram equivalents (MME) data from the patients electronic medical record and via an electronic survey sent to patients on postoperative days 1-5.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=33 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Opioid Use in Morphine Milligram Equivalents (MME)
PACU
|
0 MMEs
Interval 0.0 to 10.0
|
0 MMEs
Interval 0.0 to 17.5
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Postoperative Day 1
|
38.8 MMEs
Interval 15.0 to 45.0
|
30 MMEs
Interval 15.0 to 57.5
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Postoperative Day 2
|
25 MMEs
Interval 10.0 to 35.0
|
20 MMEs
Interval 10.0 to 40.0
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Postoperative Day 3
|
20 MMEs
Interval 0.0 to 35.0
|
15 MMEs
Interval 0.0 to 30.0
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Postoperative Day 4
|
12.5 MMEs
Interval 0.0 to 22.5
|
0 MMEs
Interval 0.0 to 30.0
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Postoperative Day 5
|
12.5 MMEs
Interval 0.0 to 20.0
|
0 MMEs
Interval 0.0 to 15.0
|
|
Opioid Use in Morphine Milligram Equivalents (MME)
Total MME Consumption (PACU through Postoperative Day 5)
|
105 MMEs
Interval 50.0 to 180.0
|
111.3 MMEs
Interval 60.0 to 150.0
|
SECONDARY outcome
Timeframe: On the day of surgery (PACU), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5Population: One subject from the liposomal bupivacaine group was lost to follow up for medication data collection and not included in the overall analysis.
The investigators will collect the use of non-opioid analgesics (ibuprofen and acetaminophen) data from the patients electronic medical record and via an electronic survey sent to patients.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=33 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Consumption of Non-opioid Analgesics
Postoperative Day 1 (Ibuprofen)
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 5 (Ibuprofen)
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 1 (Acetaminophen)
|
0 mg
Interval 0.0 to 1000.0
|
0 mg
Interval 0.0 to 975.0
|
|
Consumption of Non-opioid Analgesics
Day of surgery (PACU) Ibuprofen
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Day of surgery (PACU) Acetaminophen
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 2 (Ibuprofen)
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 2 (Acetaminophen)
|
0 mg
Interval 0.0 to 975.0
|
0 mg
Interval 0.0 to 1000.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 3 (Ibuprofen)
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 3 (Acetaminophen)
|
0 mg
Interval 0.0 to 1625.0
|
650 mg
Interval 0.0 to 2000.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 4 (Ibuprofen)
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 4 (Acetaminophen)
|
0 mg
Interval 0.0 to 2000.0
|
0 mg
Interval 0.0 to 1300.0
|
|
Consumption of Non-opioid Analgesics
Postoperative Day 5 (Acetaminophen)
|
0 mg
Interval 0.0 to 6500.0
|
0 mg
Interval 0.0 to 1300.0
|
|
Consumption of Non-opioid Analgesics
Total Ibuprofen
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Consumption of Non-opioid Analgesics
Total Acetaminophen
|
650 mg
Interval 0.0 to 6500.0
|
3000 mg
Interval 0.0 to 6000.0
|
SECONDARY outcome
Timeframe: On Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative Day 5, and Postoperative Day 30The investigators will monitor patients for any adverse reaction to the interscalene block by distributing an electronic survey asking if the following symptoms/scenarios occured: persistent numbness/tingling/weakness, tinnitus, metallic taste, irregular heartbeat, seizures, ER or hospital admission. On day 30, only the questions about persistent numbness/tingling/weakness and ER or hospital admission were asked.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=34 Participants
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 Participants
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Adverse Block Event Survey
Tinnitus/ringing in ears · Postoperative Day 5
|
4 Participants
|
4 Participants
|
|
Adverse Block Event Survey
Persistent numbness/tingling/weakness · Postoperative Day 5
|
5 Participants
|
7 Participants
|
|
Adverse Block Event Survey
Metallic Taste · Postoperative Day 5
|
3 Participants
|
1 Participants
|
|
Adverse Block Event Survey
Irregular Heartbeat · Postoperative Day 5
|
0 Participants
|
0 Participants
|
|
Adverse Block Event Survey
Seizures · Postoperative Day 5
|
0 Participants
|
0 Participants
|
|
Adverse Block Event Survey
ER or hospital admission · Postoperative Day 5
|
6 Participants
|
6 Participants
|
Adverse Events
Liposomal Bupivacaine Group
Plain Bupivacaine Group
Serious adverse events
| Measure |
Liposomal Bupivacaine Group
n=34 participants at risk
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 participants at risk
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospital admission for acute low back pain
|
2.9%
1/34 • From enrollment until end of follow-up on postoperative day 30.
|
0.00%
0/33 • From enrollment until end of follow-up on postoperative day 30.
|
Other adverse events
| Measure |
Liposomal Bupivacaine Group
n=34 participants at risk
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
|
Plain Bupivacaine Group
n=33 participants at risk
36 mL (180 mg) 0.5% bupivacaine
|
|---|---|---|
|
Injury, poisoning and procedural complications
Persistent numbness, tingling, and weakness
|
14.7%
5/34 • From enrollment until end of follow-up on postoperative day 30.
|
21.2%
7/33 • From enrollment until end of follow-up on postoperative day 30.
|
|
Injury, poisoning and procedural complications
Tinnitus
|
11.8%
4/34 • From enrollment until end of follow-up on postoperative day 30.
|
12.1%
4/33 • From enrollment until end of follow-up on postoperative day 30.
|
|
Injury, poisoning and procedural complications
Metallic Taste
|
8.8%
3/34 • From enrollment until end of follow-up on postoperative day 30.
|
3.0%
1/33 • From enrollment until end of follow-up on postoperative day 30.
|
|
General disorders
ER or hospital admission lasting <24 hours within 30 days of surgery
|
17.6%
6/34 • From enrollment until end of follow-up on postoperative day 30.
|
18.2%
6/33 • From enrollment until end of follow-up on postoperative day 30.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place