Status:
UNKNOWN
Transversus Abdominis Plane Catheter Following Kidney Transplantation
Lead Sponsor:
Western University, Canada
Conditions:
Pain, Postoperative
Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 anesthe...
Eligibility Criteria
Inclusion
- 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
- 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.
- Age \<18 years (this analgesic approach has not been established in this population).
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04786470
Start Date
May 1 2021
End Date
November 1 2022
Last Update
March 8 2021
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