Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

Summary

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

Timeline

Start

2016-02-29

Primary completion

2018-02-26

Completion

2018-03-08

Outcome

Missed primary endpoint

Stopped: “Interim analysis showed that there was no difference between the two drugs”

registry MEDIAN Group 1: Bupivicaine: Total: 300 (108 to 684) mg MEDIAN Group 2: Liposomal Bupivacaine: Total: 283 (90 to 765) mg NCT02662036 ↗

registry analysis (superiority test); Group 1: Bupivicaine vs Group 2: Liposomal Bupivacaine; p = 0.98; Mann Whitney U Test NCT02662036 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	266 mg	Other
Comparator	Bupivicaine	Other / unclassified	0.25 %	Other

Indications

No indication recorded.