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Transversus Abdominis Plane (TAP) Block After Kidney Transplantation

NCT ID: NCT01496729

Last Updated: 2013-10-10

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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Postoperative pain is a major problem in patients who either donate a kidney or undergo kidney transplantation. This pain is commonly treated with opioids, which can cause several side effects, ranging from pruritus, impaired vigilance, and most concerning to severe respiratory depression. This can be aggravated in the recipient by accumulation of opioid metabolites secondary to renal impairment and secretion.

Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP) block after surgery in the lower abdomen. In the proposed study, we plan to compare the impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a ultrasound guided sham block with normal saline (placebo) on postoperative pain scores, postoperative opioid consumption, as well as patient's satisfaction.

The investigators hypothesize, that patients who receive a TAP block will have lower postoperative pain scores, lower postoperative opioid consumption as well as higher satisfaction scores.

Detailed Description

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Conditions

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Transplantation, Kidney

Keywords

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Kidney transplantation Transversus abdominis plane (TAP) block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transversus abdominis plane (TAP) block with ropivacaine

A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane (TAP) block

Intervention Type PROCEDURE

A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure.

Sham TAP block with normal saline

A sham TAP block with normal saline will be performed at the end of the surgical procedure.

Group Type SHAM_COMPARATOR

Sham TAP block with normal saline

Intervention Type PROCEDURE

A sham TAP block with normal saline will be performed at the end of the surgical procedure.

Interventions

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Transversus abdominis plane (TAP) block

A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure.

Intervention Type PROCEDURE

Sham TAP block with normal saline

A sham TAP block with normal saline will be performed at the end of the surgical procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years, English speaking, receiving a kidney transplant or donating a kidney as part of standard clinical care

Exclusion Criteria

* Allergy to local anesthetics or opioids, coagulopathy or dementia. Patients with known history of IV drug abuse and with very high preoperative opioid requirements (defined as \> 120 mg oxycodone/ day, use of methadone or fentanyl patches) will also be excluded from this study.

Coagulopathy will be assessed by the patient's history and physical. Should there be concerns regarding "easy bleeding" or "easy bruising", further workup of the patient's coagulation will be ordered (PT, PTT, INR). Since we perform the TAP block after 3-4 hours of kidney surgery, any patient with coagulopathy will most likely have been canceled prior to surgery. Therefore, we would deem any patient, who was eligible for kidney surgery, eligible for a TAP block at the end of the surgical procedure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Medical Center at Parnassus

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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11-06622

Identifier Type: -

Identifier Source: org_study_id