Transversus Abdominis Plane Catheter Following Kidney Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Oral morphine equivalent (OME) [48 hours post kidney transplantation]
OME in mg
Secondary Outcome Measures
- 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.
- Creatinine (mmol/L) at time of discharge [Duration of admission]
- Length of stay [Duration of admission]
Eligibility Criteria
Criteria
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.
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Age <18 years (this analgesic approach has not been established in this population).
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Western University, Canada
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 116618