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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Transplant;Failure,Kidney
• Intervention / Treatment: Drug: Ropivacaine Continuous Infusion Catheter; Drug: Single Dose Liposomal Bupivicaine

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Natasha Piniero, BS; Phone Number: 916-734-5171; Email: nspiniero@ucdavis.edu
• Study Contact Backup: Name: Ana Arias, BS; Phone Number: 916-703-5456; Email: apaarias@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis
      • Contact: Natasha Piniero, BS; Phone Number: 916-734-5171; Email: nspiniero@ucdavis.edu
      • Principal Investigator: Richard Applegate, MD
      • Contact: Ana Arias, BS; Phone Number: 916-703-5456; Email: apaarias@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: TAP block initiated with ropivacaine bolus and infusion
Active Comparator: 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.	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.; Other Names: TAP block with liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Post Operative Nausea	Count of post operative nausea episodes	Through 4 days following renal transplant surgery
Post Operative Vomiting	Count of post operative vomiting events	Through 4 days following renal transplant
Respiratory Depression	Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute	Through 4 days following renal transplant surgery
Post Operative Care Unit and Hospital Length of Stay	Length of Stay	Up to 2 weeks following renal transplant surgery
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

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Ropivacaine; Transversus Abdominis Plane Block; Liposomal bupivacaine
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain, Postoperative; Renal Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 1205738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No