Transversus Abdominis Plane Catheter Following Kidney Transplantation
NCT ID: NCT04786470
Last Updated: 2021-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2021-05-31
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transversus Abdominis Plane Block During Kidney Transplant Surgery
NCT02080728
TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant
NCT03737604
Does an Abdominal Wall Nerve Block During Surgery Help Reduce Pain From Kidney Transplantation?
NCT05280197
Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
NCT03149783
Transversus Abdominis Plane Catheter: a Study of Method
NCT01395043
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Local Anaesthetic Infusion
Ropivacaine
Ropivacaine infusion via transversus abdominis plane catheter.
Saline Infusion
Saline
Saline infusion via transversus abdominis plane catheter.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ropivacaine
Ropivacaine infusion via transversus abdominis plane catheter.
Saline
Saline infusion via transversus abdominis plane catheter.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western University, Canada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrew Rasmussen
Kidney and Pancreas Transplantation Fellow
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
116618
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.