Transversus Abdominis Plane Catheter Following Kidney Transplantation

Western University, Canada

Status and phase: Unknown; Phase 3

Conditions: Pain, Postoperative; Kidney Transplant

Treatments: Drug: Ropivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04786470

116618

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Local Anaesthetic Infusion

Active Comparator group

Treatment:

Drug: Ropivacaine

Saline Infusion

Sham Comparator group

Treatment:

Drug: Saline