Transversus Abdominis Plane Catheter Following Kidney Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Transversus Abdominis Plane Catheter Following Kidney Transplantation

Conditions
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Pain, Postoperative, Kidney Transplant

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male, female, non-binary gender, aged >18 years. 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 No history of allergy to any local anesthetic. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration Exclusion Criteria: Current use of opioid pain medications prior to kidney transplantation. Known allergic reactions to components of any local anesthetic medication. Prior local anesthetic systemic toxicity. History of chronic pain undergoing current active treatment for the same. Age <18 years (this analgesic approach has not been established in this population). Unable or unwilling to use IV PCA pump for any reason (manual dexterity, cognitive impairment, patient choice etc.). Multi-visceral transplantation. Incision other than standard Gibson incision. Unilateral or bilateral nephrectomy at time of kidney transplant. Advanced liver disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Anaesthetic Infusion<br> | Drug: Ropivacaine<br>* Ropivacaine infusion via transversus abdominis plane catheter.<br>|
| Sham Comparator: Saline Infusion<br> | Drug: Saline<br>* Saline infusion via transversus abdominis plane catheter.<br>|

What is the study measuring?
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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 |