Transversus Abdominis Plane Catheter Following Kidney Transplantation

Phase 3

• Conditions: Pain, Postoperative; Kidney Transplant
• Interventions: Drug: Ropivacaine; Drug: Saline

• Registration Number: NCT04786470
• Lead Sponsor: Western University, Canada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08
• Study Start: 2021-05
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anaesthetic Infusion	Ropivacaine	-
Saline Infusion	Saline	-

Primary Outcome Measures

Name	Time	Method
Oral morphine equivalent (OME)	48 hours post kidney transplantation	OME in mg

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale pain rating	12, 24, and 48 hours post kidney transplantation	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.
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	Duration of admission	Defined as the requirement for hemodialysis/peritoneal dialysis within the first 7 days after kidney transplantation for any reason.
Length of stay	Duration of admission
Creatinine (mmol/L) at time of discharge	Duration of admission