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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737604
• Other study ID #: 1205738
• Status: Recruiting
• Phase: Phase 4
• Start date: October 4, 2018
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: Ana Arias, BS
• Phone: 916-703-5456
• Email: apaarias[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of pain scores indicating severe pain	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)	Through 4 days following renal transplant surgery
Secondary	Post Operative Nausea	Count of post operative nausea episodes	Through 4 days following renal transplant surgery
Secondary	Post Operative Vomiting	Count of post operative vomiting events	Through 4 days following renal transplant
Secondary	Respiratory Depression	Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute	Through 4 days following renal transplant surgery
Secondary	Post Operative Care Unit and Hospital Length of Stay	Length of Stay	Up to 2 weeks following renal transplant surgery
Secondary	Acquisition Costs Related to Analgesia	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	Up to 2 weeks following renal transplant surgery

External Links

•   Learn more or sign up for the study here!