Clinical trial NCT04786470: Transversus Abdominis Plane Catheter Following Kidney Transplantation
Official title: Transversus Abdominis Plane Catheter Following Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Kidney Transplant
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oral morphine equivalent (OME)
timeFrame: 48 hours post kidney transplantation
Secondary outcomes:
measure: Visual Analog Scale pain rating
timeFrame: 12, 24, and 48 hours post kidney transplantation
measure: Patient quality of life score
timeFrame: 48 hours post kidney transplantation
measure: Time to return of bowel function postoperatively
timeFrame: Duration of admission
measure: Incidence of local anesthetic systemic toxicity
timeFrame: Duration of admission
measure: Postoperative adverse events (surgical)
timeFrame: Duration of admission
measure: Delayed graft function
timeFrame: Duration of admission
measure: Creatinine (mmol/L) at time of discharge
timeFrame: Duration of admission
measure: Length of stay
timeFrame: Duration of admission
Other outcomes:
Locations:
Study officials:
References: