Phase 4
N=54
Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair
Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT03149887 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Numeric Rating Pain Score [NRS] at Time of Block Resolution — 5.4; 5.8 Score on a scale — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal bupivacaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Steven Orebaugh
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Pain Score [NRS] at Time of Block Resolution |
5.4; 5.8 | 0.66 |
| SECONDARY Mean NRS Pain Score at Rest on Postoperative Day 1 |
5.7; 6.1 | 0.54 |
| SECONDARY Mean NRS Pain Score at Rest on Postoperative Day 2 |
5.2; 6.4 | 0.07 |
| SECONDARY Mean NRS Pain Scores at Rest on Postoperative Day 3 |
4.6; 6.3 | 0.003 sig |
| SECONDARY Mean NRS Pain Score With Motion |
4.5; 5.1 | 0.53 |
| SECONDARY Oral Analgesic Requirements on Postoperative Day 1 |
42.9; 41.4 | 0.84 |
| SECONDARY Oral Analgesic Requirements on Postoperative Day 2 |
36.6; 39.0 | 0.76 |
| SECONDARY Oral Analgesic Requirements on Postoperative Day 3 |
29.8; 36.4 | 0.44 |
Summary
Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for postoperative pain control after total knee, total hip and total shoulder arthroplasty. We are conducting a randomized, controlled trial to evaluate pain control after arthroscopic rotator cuff repair in ambulatory patients, comparing standard care in the control group, with standard care plus the addition of injection of liposomal bupivacaine in the experimental group.
Eligibility Criteria
Inclusion Criteria
- Adult patients up to age 65 years, undergoing elective, ambulatory, arthroscopic rotator cuff repair.
Exclusion Criteria
- Pregnancy, coagulopathy, allergy to bupivacaine, renal failure, hepatic insufficiency, and/or inappropriate candidate for usual therapy (specifically, if unable to receive the usual preoperative interscalene nerve block: preexisting nerve injury on side of surgery, refusal of nerve block, infection at site of nerve block).
Data sourced from ClinicalTrials.gov (NCT03149887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.