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

NCT03737604 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1205738
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplant;Failure,Kidney; Pain, Postoperative

Keywords

Transversus Abdominis Plane Block; Ropivacaine; Liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• Difference in Total Opioid Consumption

  Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg

  Through 4 days following renal transplant surgery

Secondary Outcomes (6)

• Proportion of pain scores indicating severe pain

  Through 4 days following renal transplant surgery

• Post Operative Nausea

  Through 4 days following renal transplant surgery

• Post Operative Vomiting

  Through 4 days following renal transplant

• Respiratory Depression

  Through 4 days following renal transplant surgery

• Post Operative Care Unit and Hospital Length of Stay

  Up to 2 weeks following renal transplant surgery

Study Arms (2)

Ropivacaine Continuous Infusion Catheter

ACTIVE COMPARATOR

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.

Drug: Ropivacaine Continuous Infusion Catheter

Single dose liposomal bupivicaine

ACTIVE COMPARATOR

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.

Drug: Single Dose Liposomal Bupivicaine

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.

Also known as: TAP block initiated with ropivacaine bolus and infusion

Ropivacaine Continuous Infusion Catheter

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.

Also known as: TAP block with liposomal bupivacaine

Single dose liposomal bupivicaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 18 years or older
• Renal Transplant Recipients

You may not qualify if:

• Patients less than 18 years of age
• Pregnant Women
• Prisoners
• Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia
• Patients on Systemic anti coagulation
• Patients unable to provide consent
• Hypersensitivity to amide-type local anesthetic or any component of the drug formula

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Ana Arias, BS

CONTACT

916-703-5456; apaarias@ucdavis.edu

Natasha Piniero, BS

CONTACT

916-734-5171; nspiniero@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unable to mask based on physical characteristics of liposomal bupivacaine
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: November 9, 2018
• Study Start: October 4, 2018
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)