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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hartford Hospital
Study ID
NCT05972018
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 18, 2023
Status verified
Mar 2025
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: RSB LB/B
    Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
  • Active Comparator: RSB/RSC Ropivacaine
    Rectus Sheath Block: Total 60mL of 0.2% ropivacaine (3 vials) (30mL per side) \+ Rectus Sheath Catheter intermittent hourly boluses of 0.2% ropivacaine 10mL/hr per side

Primary Outcome Measure

The cost of care during hospitalization. [ Time Frame: From the time of the blocks until the date of discharge, assessed as 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06102
Kevin J Finkel, MD
[email protected]
Aseel Walker, MD
[email protected]
860-9772-1778

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By research site
Hartford Hospital· Hartford, CT

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