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

University of California (UC) Davis

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative; Transplant;Failure,Kidney

Treatments: Drug: Single Dose Liposomal Bupivicaine; Drug: Ropivacaine Continuous Infusion Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03737604

1205738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ropivacaine Continuous Infusion Catheter

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine Continuous Infusion Catheter

Single dose liposomal bupivicaine

Active Comparator group

Description:

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.

Treatment:

Drug: Single Dose Liposomal Bupivicaine