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

Study acronym: EXODUS
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment target: 50 to 14v5 Show 6 more changesShow less
    • Primary completion date: Oct 30, 2025 to Oct 30, 2026
    • Primary endpoints: 1 to 3
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: 15 to 10
    • Study title expanded, about 2 words
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 2025 to Oct 30, 2025
    • Study completion date: Dec 2025 to Dec 30, 2025
    • Start date changed from estimate of Sep 2023 to Oct 18, 2023
  3. Interventions: Liposomal bupivacaine (Drug), Ropivacaine (Drug) to Bupivacain (Drug), Liposomal bupivacaine (Drug), Ropivacaine (Drug)
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints: 11 to 15
    v3
  4. Secondary endpoints revised (11)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05972018
Lead Sponsor Hartford Hospital
Conditions
(from sponsor)		 Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion, Aortoiliac Occlusive Disease, Aortic Diseases
Related terms Aortic Aneurysm, Abdominal, Aortic Diseases
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov