NCT05972018

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

Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks And Catheters With Intermittent Hourly Boluses.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Aneurysm, Abdominal
• Abdominal Aortic Occlusion
• Aortoiliac Occlusive Disease
• Aortic Diseases

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
DRUG	Ropivacaine	Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
DRUG	Bupivacain	Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Timeline

• Start date: 2023-10-18
• Primary completion: 2026-10-30
• Completion: 2026-12-30
• First posted: 2023-08-02
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study