Transversus Abdominus Plane Block

NCT ID: NCT01054469

Last Updated: 2012-06-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-02-29

Brief Summary

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Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.

Detailed Description

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Conditions

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Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TAP block with placebo

Group Type PLACEBO_COMPARATOR

TAP block placement with placebo

Intervention Type PROCEDURE

20 ml of normal saline (placebo)

TAP block with ropivacaine

Group Type ACTIVE_COMPARATOR

Placement of block with ropivacaine

Intervention Type PROCEDURE

20 ml of 0.5% ropivacaine hydrochloride

Interventions

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TAP block placement with placebo

20 ml of normal saline (placebo)

Intervention Type PROCEDURE

Placement of block with ropivacaine

20 ml of 0.5% ropivacaine hydrochloride

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who are ≥ 18 and ≤ 80 years of age.
* Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.

Exclusion Criteria

* Patients scheduled to undergo an open procedure for nephrectomy
* Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
* Bilateral nephrectomy
* Pregnant or lactating patients
* Patients unable or unwilling to provide informed consent
* Patients unable to comprehend the use of a visual analog scale
* Patients desiring preemptive antiemetics
* Opioid tolerance
* Allergy to amide local anesthetics or any of the study drugs (morphine).
* Contraindication to regional nerve block (bleeding disorder, infection at site of block)
* Patients with history of dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Stephen Aniskevich, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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08-003563

Identifier Type: -

Identifier Source: org_study_id

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