Transversus Abdominis Plane Catheter Following Kidney Transplantation

NCT04786470 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 116618
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Oral morphine equivalent (OME)

  OME in mg

  48 hours post kidney transplantation

Secondary Outcomes (8)

• Visual Analog Scale pain rating

  12, 24, and 48 hours post kidney transplantation

• 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

• Postoperative adverse events (surgical)

  Duration of admission

Study Arms (2)

Local Anaesthetic Infusion

ACTIVE COMPARATOR

Drug: Ropivacaine

Saline Infusion

SHAM COMPARATOR

Drug: Saline

Interventions

Ropivacaine DRUG

Ropivacaine infusion via transversus abdominis plane catheter.

Local Anaesthetic Infusion

Saline DRUG

Saline infusion via transversus abdominis plane catheter.

Saline Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Andrew C Rasmussen, MD

CONTACT

arasmuss@ualberta.ca

Ephraim Tang, MD

CONTACT

ephraim.tang@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kidney and Pancreas Transplantation Fellow

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share