Phase 4
N=42
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Shoulder Pain · Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT01977352 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Total Opioid Consumption — 2; 2.75; 1.94; 3.33 number of percocet tabs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal bupivacaine (Drug); Bupivacaine 0.25% (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption |
2; 2.75; 1.94; 3.33; 2.06; 3.63 | — |
| SECONDARY Quality of Analgesia |
5.23; 6.4; 4.9; 6.13; 5.18; 5.14 | — |
| SECONDARY Sensory and Motor Block |
1.6; 1.31; 2.8; 2.33; 1.78; 1.08 | — |
| SECONDARY Time to First Pain Medicine |
1148; 702.89 | — |
| SECONDARY Time to Discharge Home |
— | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting |
33.33; 36.84 | — |
| SECONDARY Sleep Quality |
5.06; 3.86; 6.58; 6; 6.75; 6.3 | — |
Summary
The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
Eligibility Criteria
Inclusion Criteria
- English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.
Exclusion Criteria
- Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.
Data sourced from ClinicalTrials.gov (NCT01977352). 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.