Transversus Abdominis Plane Catheter Following Kidney Transplantation

Continuous Infusion of Local Anesthetic After Kidney Transplantation

This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard postoperative analgesia in patients undergoing kidney transplantation. Patients will have a TAP catheter placed at the time of kidney transplantation by the surgical team under direct vision. They are then randomized to a continuous infusion of local anesthetic or saline for 48 hours postoperatively. Both groups will receive a standard postoperative analgesic regimen including a Patient Controlled Analgesic (PCA) pump and multimodal analgesics including acetaminophen and gabapentin.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Kidney Transplant
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, female, non-binary gender, aged >18 years.
4. Undergoing a kidney transplant (deceased or living donor) as treatment for stage 5 chronic kidney disease (Glomerular filtration rate < 15ml/min) either on dialysis, or approaching dialysis
5. No history of allergy to any local anesthetic.
6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. Current use of opioid pain medications prior to kidney transplantation.
2. Known allergic reactions to components of any local anesthetic medication.
3. Prior local anesthetic systemic toxicity.
4. History of chronic pain undergoing current active treatment for the same.
5. Age <18 years (this analgesic approach has not been established in this population).
6. Unable or unwilling to use IV PCA pump for any reason (manual dexterity, cognitive impairment, patient choice etc.).
7. Multi-visceral transplantation.
8. Incision other than standard Gibson incision.
9. Unilateral or bilateral nephrectomy at time of kidney transplant.
10. Advanced liver disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Anaesthetic Infusion	Drug: Ropivacaine; Ropivacaine infusion via transversus abdominis plane catheter.
Sham Comparator: Saline Infusion	Drug: Saline; Saline infusion via transversus abdominis plane catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral morphine equivalent (OME)	OME in mg	48 hours post kidney transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale pain rating	Series of 5 faces that depict discomfort levels ranging from severe pain (score 5) to no pain at all (score 1). The higher the score, the more pain a patient has.	12, 24, and 48 hours post kidney transplantation
Patient quality of life score		48 hours post kidney transplantation
Time to return of bowel function postoperatively		Duration of admission
Incidence of local anesthetic systemic toxicity		Duration of admission
Postoperative adverse events (surgical)		Duration of admission
Delayed graft function	Defined as the requirement for hemodialysis/peritoneal dialysis within the first 7 days after kidney transplantation for any reason.	Duration of admission
Creatinine (mmol/L) at time of discharge		Duration of admission
Length of stay		Duration of admission

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 116618

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