drugset / Trial / NCT03474510

Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

NCT03474510 ↗

Phase 4 Withdrawn TriHealth Inc.
RandomizedParallel-groupOpen-labelSupportive care

Summary

The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Timeline

Start
2018-03-17
Primary completion
2019-02-01
Completion
2019-02-01

Outcome

Outcome not reported

Stopped: “Investigator Decision”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 266 mg Other

Indications