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

Phase 4

Recruiting

• Conditions: Transplant;Failure,Kidney; Pain, Postoperative
• Interventions: Drug: Ropivacaine Continuous Infusion Catheter; Drug: Single Dose Liposomal Bupivicaine

• Registration Number: NCT03737604
• Lead Sponsor: University of California, Davis

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.

Detailed Description

This study is a comparison of the analgesic efficacy of TAP blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

In the Liposomal Bupivacaine group, 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.

For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5 mls 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 ropivacaine. 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.

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-06-12
• Study Completion: 2025-06-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients ages 18 years or older
• Renal Transplant Recipients

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine Continuous Infusion Catheter	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.
Single dose liposomal bupivicaine	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 Measures

Name	Time	Method
Difference in Total Opioid Consumption	Through 4 days following renal transplant surgery	Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg

Secondary Outcome Measures

Name	Time	Method
Post Operative Nausea	Through 4 days following renal transplant surgery	Count of post operative nausea episodes
Post Operative Vomiting	Through 4 days following renal transplant	Count of post operative vomiting events
Respiratory Depression	Through 4 days following renal transplant surgery	Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute
Post Operative Care Unit and Hospital Length of Stay	Up to 2 weeks following renal transplant surgery	Length of Stay
Acquisition Costs Related to Analgesia	Up to 2 weeks following renal transplant surgery	Analgesia Related Costs defined as the sum of hospital specific costs to acquire medications and supplies needed to perform block or administer analgesic and local anesthetic medications
Proportion of pain scores indicating severe pain	Through 4 days following renal transplant surgery	Proportion of pain scores 7 or higher indicating severe pain as determined by patient report of pain using verbal pain score from 0 (no pain) to10 (most severe pain)

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States