Kidney Transplant, Pain, Postoperative
Conditions
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.
Interventions
DRUGRopivacaine
Ropivacaine infusion via transversus abdominis plane catheter.
DRUGSaline
Saline infusion via transversus abdominis plane catheter.
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral morphine equivalent (OME) | 48 hours post kidney transplantation | OME in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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 | — |
| Postoperative adverse events (surgical) | Duration of admission | — |
Contacts
Primary ContactAndrew C Rasmussen, MD
Backup ContactEphraim Tang, MD
Outcome results
None listed