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

June 2, 2010 updated by: Hunter Colorectal Research

Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
      • New Lambton, New South Wales, Australia, 2305
        • Newcastle Private Hospital
      • New Lambton, New South Wales, Australia, 2305
        • Private Medical Suites
      • Waratah, New South Wales, Australia, 2298
        • Mater Misericordiae Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.
Procedure: US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
Other Names:
  • TAP Block
Active Comparator: 2
Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.
Procedure: US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
Other Names:
  • TAP Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mg/kg of morphine equivalent used by patients post operatively.
Time Frame: From operation until discharge.
From operation until discharge.

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung Function (spirometry), including FVC, FEV1 and PEFR
Time Frame: 24, 48 and 72 hours postoperatively
24, 48 and 72 hours postoperatively
Visual Analogue Scale for pain at rest, deep breathing and coughing.
Time Frame: 24, 48 and 72 hours postoperatively
24, 48 and 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter Colorectal Research

Investigators

  • Principal Investigator: Brian Draganic, B.Med.,B.Med.Sci.(Hons),FRACS, Hunter Colorectal Research
  • Principal Investigator: Stephen Smith, B.Med.,F.R.A.C.S., Hunter Colorectal Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPTRIAL
  • 08/02/20/3.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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