Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery

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

PHASE1

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-12-31

Brief Summary

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The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.

TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.

This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.

Group Type ACTIVE_COMPARATOR

US-Guided Ropivacaine TAP Block

Intervention Type PROCEDURE

Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.

2

Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.

Group Type ACTIVE_COMPARATOR

US-Guided Ropivacaine TAP Block

Intervention Type PROCEDURE

Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.

Interventions

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US-Guided Ropivacaine TAP Block

Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.

Intervention Type PROCEDURE

Other Intervention Names

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TAP Block

Eligibility Criteria

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Inclusion Criteria

* All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.

Exclusion Criteria

* History of adverse reaction to Ropivicaine or similar drug.
* Inability or refusal to give consent
* Coagulopathic
* Severe renal impairment
* Aged \<18 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No