Trial Outcomes & Findings for Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair (NCT NCT03149887)
NCT ID: NCT03149887
Last Updated: 2020-01-23
Results Overview
Numeric rating score pain level at time of nerve block resolution, on scale of 0-10, as reported by patient at time of 24 hour follow up phone call. A reported score of zero implies no pain, whereas a score of "10" implies very severe pain. Outcome score is mean of reported pain scores by participants at time of nerve block resolution.
COMPLETED
PHASE4
54 participants
At the time of block resolution, as reported by patients at follow up phone call
2020-01-23
Participant Flow
54 patients recruited at time of presentation for surgery. These 54 received the injection of either liposomal bupivacaine (experimental group) or normal saline (control group).
Participant milestones
| Measure |
Experimental (Liposomal Bupivacaine)
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
Injection of Placebo solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Normal saline in same volume as exparel injection in experimental group
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
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 |
Experimental (Liposomal Bupivacaine)
n=27 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=27 Participants
Injection of normal saline in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Normal saline in volume equal to that of the liposomal bupivacine injected in experimental group
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 7.2 • n=27 Participants
|
56.3 years
STANDARD_DEVIATION 7.8 • n=27 Participants
|
57.3 years
STANDARD_DEVIATION 7.6 • n=54 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=27 Participants
|
13 Participants
n=27 Participants
|
26 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=27 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: At the time of block resolution, as reported by patients at follow up phone callNumeric rating score pain level at time of nerve block resolution, on scale of 0-10, as reported by patient at time of 24 hour follow up phone call. A reported score of zero implies no pain, whereas a score of "10" implies very severe pain. Outcome score is mean of reported pain scores by participants at time of nerve block resolution.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=27 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=27 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Numeric Rating Pain Score [NRS] at Time of Block Resolution
|
5.4 Score on a scale
Standard Deviation 2.6
|
5.8 Score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Postoperative day 1Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Mean NRS pain score on scale of 1-10, at rest (zero is no pain, 10 is severe pain). Patients recorded their pain score at rest with administration of each oral analgesic tablet. Outcome score is mean of reported pain scores for this day.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Mean NRS Pain Score at Rest on Postoperative Day 1
|
5.7 Score on a scale
Standard Deviation 2.2
|
6.1 Score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Postoperative day 2Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Mean of patient-reported NRS pain scores on postoperative day 2. Patients recorded pain scores at rest with each oral analgesic tablet taken. Zero implies no pain, whereas a score of 10 translates to very severe pain. Outcome score is mean of reported pain scores for this day.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Mean NRS Pain Score at Rest on Postoperative Day 2
|
5.2 score on a scale
Standard Deviation 2.3
|
6.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Postoperative Day 3Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Patients recorded their pain scores at rest with ingestion of each oral analgesic table on postoperative day 3. Zero implies no pain, whereas 10 implies very severe pain. Outcome score is mean of reported pain scores for this day.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Mean NRS Pain Scores at Rest on Postoperative Day 3
|
4.6 score on a scale
Standard Deviation 1.7
|
6.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Mean value of reported pain scores on postoperative days 1,2 and 3Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
NRS Pain score with passive motion (for those patients who performed this), on 0-10 scale, with zero being no pain and 10 representing severe pain. Outcome score is mean of reported pain scores for passive motion episodes on all three postoperative days.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Mean NRS Pain Score With Motion
|
4.5 Score on a scale
Standard Deviation 3.3
|
5.1 Score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Postoperative day 1Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Oral analgesic dose (5 mg oxycodone tablets) required expressed as oral morphine equivalents. Outcome is total oral opioid used on postoperative day 1 expressed as oral morphine equivalents in mg.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Oral Analgesic Requirements on Postoperative Day 1
|
42.9 Oral morphine equivalents in mg
Standard Deviation 22.3
|
41.4 Oral morphine equivalents in mg
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Postoperative day 2Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Amount of oral opioids (oxycodone 5 mg tablets) ingested by patients on Postoperative Day 2, expressed as Oral Morphine Equivalents in mg.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Oral Analgesic Requirements on Postoperative Day 2
|
36.6 Oral morphine equivalents in mg
Standard Deviation 30.3
|
39.0 Oral morphine equivalents in mg
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Postoperative Day 3Population: These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.
Patients reported the number of oral analgesic tablets (5 mg oxycodone tablets) ingested on postoperative day 3. This is expressed as Oral Morphine Equivalents in mg.
Outcome measures
| Measure |
Experimental (Liposomal Bupivacaine)
n=26 Participants
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=25 Participants
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Oral Analgesic Requirements on Postoperative Day 3
|
29.8 Oral morphine equivalents in mg
Standard Deviation 34.9
|
36.4 Oral morphine equivalents in mg
Standard Deviation 24.6
|
Adverse Events
Experimental (Liposomal Bupivacaine)
Control (Normal Saline)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental (Liposomal Bupivacaine)
n=27 participants at risk；n=26 participants at risk
Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.
Liposomal bupivacaine: Liposomal bupivacaine solution (Exparel) for injection
|
Control (Normal Saline)
n=27 participants at risk；n=25 participants at risk
Injection of saline solution in surgical field at end of arthroscopic rotator cuff repair.
Placebo: Saline solution injected in surgical field in same volume as liposomal bupivacaine injected in experimental group.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.8%
4/27 • The first three postoperative days.
|
22.2%
6/27 • The first three postoperative days.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
3/27 • The first three postoperative days.
|
11.1%
3/27 • The first three postoperative days.
|
|
General disorders
Insomnia
|
25.9%
7/27 • The first three postoperative days.
|
37.0%
10/27 • The first three postoperative days.
|
|
General disorders
Fever
|
7.4%
2/27 • The first three postoperative days.
|
0.00%
0/27 • The first three postoperative days.
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • The first three postoperative days.
|
7.4%
2/27 • The first three postoperative days.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • The first three postoperative days.
|
0.00%
0/27 • The first three postoperative days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
9/27 • The first three postoperative days.
|
22.2%
6/27 • The first three postoperative days.
|
|
General disorders
Poor appetite
|
11.1%
3/27 • The first three postoperative days.
|
14.8%
4/27 • The first three postoperative days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place