The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation

NCT ID: NCT01679106

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-05-31

Brief Summary

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Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.

Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA

The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.

The investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fentanyl IV PCA and placebo TAP catheter

Patients will receive Fentanyl IV PCA and placebo TAP catheter.

Group Type PLACEBO_COMPARATOR

Fentanyl IV PCA and placebo TAP catheter

Intervention Type OTHER

Patients will receive placebo TAP catheter with Fentanyl IV PCA.

TAP catheter with continuous infusion of Ropivicaine

Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.

Group Type ACTIVE_COMPARATOR

TAP catheter with Ropivicaine

Intervention Type OTHER

Patients will receive TAP catheter with continuous infusion of Ropivicaine.

Interventions

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TAP catheter with Ropivicaine

Patients will receive TAP catheter with continuous infusion of Ropivicaine.

Intervention Type OTHER

Fentanyl IV PCA and placebo TAP catheter

Patients will receive placebo TAP catheter with Fentanyl IV PCA.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient is \>18 years of age
* The patient has provided written informed consent and understands the explanation of the protocol.
* The patient is scheduled to have a unilateral renal transplant with a flank incision

Exclusion Criteria

* Patients aged \<18.
* Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.
* Patients who are unable to understand the verbal analog pain scale.
* Patients who decline participation.
* Patients with a midline abdominal incision.
* Combined transplants, ie. Kidney-pancreas
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ehab Farag, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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12-559

Identifier Type: -

Identifier Source: org_study_id

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