Phase 4
Completed N=78
Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery
Rotator cuff tear · Pain, Postoperative
Source: ClinicalTrials.gov NCT03822182 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Patient Reported Postoperative Pain: VAS — 3.1; 3.5; 2.4; 3.3 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.
Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Postoperative Pain: VAS |
3.1; 3.5; 2.4; 3.3; 2.8; 2.8 | — |
| SECONDARY Patient Reported Post Operative Opioid Use |
26.5; 22.8; 18.8; 36.1; 21.9; 22.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 and older
- Primary diagnosis of rotator cuff tear
- Able to provide informed consent
- Is willing and able to accept text messages
Exclusion Criteria
- Known allergies to the study medications.
- Known narcotic or alcohol abuse (< 3 months)
- Revision rotator cuff surgery
- Contraindication to regional anesthesia
- Current narcotic regimen or contract with pain management specialist
- Diagnosed with any of the following co-morbidities:
- Pre-existing coagulation disorder
Data sourced from ClinicalTrials.gov (NCT03822182). 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. Informational only — not medical advice.