drugset / Trial / NCT05972018

Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters

NCT05972018 ↗

Phase 4 Recruiting 14 enrolled Hartford Hospital
Non-randomizedParallel-groupOpen-labelSupportive care

Summary

The goal of this pilot study is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will assess the safety and feasibility of this approach compared to standard of care. Participants will receive either a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for differences in the rate of postoperative complications, resources consumed with each intervention, as well as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery, and hospital length of stay.

Timeline

Start
2023-10-18
Primary completion
2026-10-30
Completion
2026-12-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 1.3 % Other
Subject Bupivacaine Other / unclassified 20 ml Other
Subject Bupivacaine Other / unclassified 30 ml Other
Comparator Ropivacaine Other / unclassified 0.2 % Other
Comparator Ropivacaine Other / unclassified 60 ml Other