Clinical trial NCT03737604: TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant
Official title: Transversus Abdominis Plane (TAP) Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine: A Prospective Randomized Control Trial for Pain Control After Renal Transplant Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Transplant;Failure,Kidney
Pain, Postoperative
Keywords: Transversus Abdominis Plane Block
Ropivacaine
Liposomal bupivacaine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in Total Opioid Consumption
timeFrame: Through 4 days following renal transplant surgery
Secondary outcomes:
measure: Proportion of pain scores indicating severe pain
timeFrame: Through 4 days following renal transplant surgery
measure: Post Operative Nausea
timeFrame: Through 4 days following renal transplant surgery
measure: Post Operative Vomiting
timeFrame: Through 4 days following renal transplant
measure: Respiratory Depression
timeFrame: Through 4 days following renal transplant surgery
measure: Post Operative Care Unit and Hospital Length of Stay
timeFrame: Up to 2 weeks following renal transplant surgery
measure: Acquisition Costs Related to Analgesia
timeFrame: Up to 2 weeks following renal transplant surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References: