Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hartford Hospital
Study ID
NCT05224089
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bowel Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Bupivicaine/Bupivacaine Admixture — DRUG
    60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL
  • Bupivacaine HCL — DRUG
    80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL

Study Details

This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.

Key Dates

Start date
Apr 27, 2022
Status verified
Mar 2025
Primary completion
Nov 30, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Bupivacaine/Bupivacaine HCL
    20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
  • Active Comparator: Regular Bupivacaine Arm
    80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Primary Outcome Measure

The highest Numerical Pain Scores [ Time Frame: 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06102
Kevin J Finkel, MD
[email protected]

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Hartford Hospital· Hartford, CT

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