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Transversus Abdominis Plane Catheter Following Kidney Transplantation

Primary Purpose

Pain, Postoperative, Kidney Transplant

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ropivacaine

Saline

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Local Anaesthetic Infusion

Saline Infusion

Arm Description

Outcomes

Primary Outcome Measures

Oral morphine equivalent (OME)

OME in mg

Secondary Outcome Measures

Visual Analog Scale pain rating

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.

Patient quality of life score

Time to return of bowel function postoperatively

Incidence of local anesthetic systemic toxicity

Postoperative adverse events (surgical)

Delayed graft function

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

Length of stay

Full Information

NCT ID

NCT04786470

First Posted

March 3, 2021

Last Updated

March 5, 2021

Sponsor

Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT04786470

Brief Title

Transversus Abdominis Plane Catheter Following Kidney Transplantation

Official Title

Transversus Abdominis Plane Catheter Following Kidney Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Kidney Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Local Anaesthetic Infusion

Arm Type

Active Comparator

Arm Title

Saline Infusion

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

Ropivacaine infusion via transversus abdominis plane catheter.

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Saline infusion via transversus abdominis plane catheter.

Primary Outcome Measure Information:

Title

Oral morphine equivalent (OME)

Description

OME in mg

Time Frame

48 hours post kidney transplantation

Secondary Outcome Measure Information:

Title

Visual Analog Scale pain rating

Description

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.

Time Frame

12, 24, and 48 hours post kidney transplantation

Title

Patient quality of life score

Time Frame

48 hours post kidney transplantation

Title

Time to return of bowel function postoperatively

Time Frame

Duration of admission

Title

Incidence of local anesthetic systemic toxicity

Time Frame

Duration of admission

Title

Postoperative adverse events (surgical)

Time Frame

Duration of admission

Title

Delayed graft function

Description

Defined as the requirement for hemodialysis/peritoneal dialysis within the first 7 days after kidney transplantation for any reason.

Time Frame

Duration of admission

Title

Creatinine (mmol/L) at time of discharge

Time Frame

Duration of admission

Title

Length of stay

Time Frame

Duration of admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew C Rasmussen, MD

arasmuss@ualberta.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Ephraim Tang, MD

ephraim.tang@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Transversus Abdominis Plane Catheter Following Kidney Transplantation

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