drugset / Trial / NCT03250507

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

NCT03250507 ↗

Phase 4 Completed 90 enrolled Henry Ford Health System
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Timeline

Start
2017-03-13
Primary completion
2019-01-30
Completion
2019-01-30

Outcome

Missed primary endpoint

paper and 51 [24-84] min in group mixture (P = 0.20). PMID 33432496 ↗

paper 203 [153-283] mg in group liposomal, and 202 [116-325] mg in group mixture (P = 0.92). PMID 33432496 ↗

paper mixture of liposomal bupivacaine with plain bupivacaine for TAP block did not improve analgesia compared with either liposomal bupivacaine or plain bupivacaine PMID 33432496 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 20 ml Other
Subject Bupivacaine Other / unclassified 40 ml Other
Subject Bupivacaine Other / unclassified 60 ml Other

Indications

No indication recorded.