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Aortic Aneurysm, AbdominalDrugPhase 4

What this study is

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.

What's being tested

  • Liposomal bupivacaine

    Intervention · DRUG

    Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)

  • Ropivacaine

    Intervention · DRUG

    Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)

  • Bupivacain

    Intervention · DRUG

    Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Study details

Official title
Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks And Catheters With Intermittent Hourly Boluses.
Sponsor
Hartford Hospital
Conditions
Aortic Aneurysm, Abdominal · Abdominal Aortic Occlusion · Aortoiliac Occlusive Disease · Aortic Diseases
Enrolling
14 people
Starts
2023-10-18
Est. completion
2026-12-30
Design
Open-label, non-randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗