TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT03737604
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pain, Postoperative
  • Transplant;Failure,Kidney

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ropivacaine Continuous Infusion Catheter — DRUG
    For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of the ropivacaine solution. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.
  • Single Dose Liposomal Bupivicaine — DRUG
    TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.

Study Details

This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

Key Dates

Start date
Oct 4, 2018
Status verified
Feb 2026
Primary completion
Jun 12, 2026
Completion
Jun 12, 2026

Study Design

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

Arms

  • Active Comparator: Ropivacaine Continuous Infusion Catheter
    Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter.
  • Active Comparator: Single dose liposomal bupivicaine
    Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline.

Primary Outcome Measure

Difference in Total Opioid Consumption [ Time Frame: Through 4 days following renal transplant surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817
Ana Arias, BS
[email protected]
916-703-5456
Natasha Piniero, BS
[email protected]
916-734-5171
Richard Applegate, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis· Sacramento, CA

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