Transversus Abdominis Plane Catheter Following Kidney Transplantation

Western University, Canada120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Pain, Postoperative Kidney Transplant

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Oral morphine equivalent (OME)

OME in mg

Time frame: 48 hours post kidney transplantation

Secondary Outcomes

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.

Time frame: 12, 24, and 48 hours post kidney transplantation

Patient quality of life score

Time frame: 48 hours post kidney transplantation

Time to return of bowel function postoperatively