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

NCT ID: NCT03737604

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2025-06-12

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.

Conditions

Transplant;Failure,Kidney; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine Continuous Infusion Catheter

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Single Dose Liposomal Bupivicaine

Intervention Type: 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.

Interventions

Ropivacaine Continuous Infusion Catheter

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.

Intervention Type: DRUG

Single Dose Liposomal Bupivicaine

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.

Intervention Type: DRUG

Other Intervention Names

TAP block initiated with ropivacaine bolus and infusion; TAP block with liposomal bupivacaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California Davis

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ana Arias, BS

Role: CONTACT

apaarias@ucdavis.edu

916-703-5456

Natasha Piniero, BS

Role: CONTACT

nspiniero@ucdavis.edu

916-734-5171

Facility Contacts

Ana Arias, BS

Role: primary

apaarias@ucdavis.edu

916-703-5456

Natasha Piniero, BS

Role: backup

nspiniero@ucdavis.edu

916-734-5171

Related Links

https://studypages.com/s/a-study-of-the-experimental-medicine-ropivacaine-for-pain-control-after-kidney-transplant-995191/

Learn more or sign up for the study here!

Other Identifiers

1205738

Identifier Type: -

Identifier Source: org_study_id