Pectoral Fascial Plane and Serratus Anterior Plane Blocks With Bupivacaine v. Liposomal Bupivacaine

Phase 0 Completed 196 enrolled The Cleveland Clinic

RandomizedParallel-groupDouble-blindTreatment

Summary

Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Assignments will be based on computer-generated code. Clinicians will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.

Timeline

Start: 2018-11-01
Primary completion: 2024-09-19
Completion: 2024-09-19

Outcome

Missed primary endpoint

paper There was no significant treatment effect on total OBAS during the initial three postoperative days PMID 39029153 ↗

Publications

Marciniak D, Raymond D, Alfirevic A, Yalcin EK, Bakal O, Pu X, Kelava M, Duncan A, Hargrave J, Bauer A, Bustamante S, Lam L, Murthy S, Sessler DI, Turan A. Combined pectoralis and serratus anterior plane blocks with or without liposomal bupivacaine for minimally invasive thoracic surgery: A randomized clinical trial. J Clin Anesth. 2024 Oct;97:111550. doi: 10.1016/j.jclinane.2024.111550. Epub 2024 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	2.5 mg/kg	Other
Subject	Bupivacaine	Other / unclassified	150 mg	Other
Subject	Bupivacaine	Other / unclassified	266 mg	Other

Indications

No indication recorded.