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

Phase 1

Completed

• Conditions: Pain
• Interventions: Procedure: US-Guided Ropivacaine TAP Block

• Registration Number: NCT00682136
• Lead Sponsor: Hunter Colorectal Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-02
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	US-Guided Ropivacaine TAP Block	Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.
2	US-Guided Ropivacaine TAP Block	Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.

Primary Outcome Measures

Name	Time	Method
mg/kg of morphine equivalent used by patients post operatively.	From operation until discharge.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

John Hunter Hospital; 🇦🇺 New Lambton, New South Wales, Australia

Mater Misericordiae Hospital; 🇦🇺 Waratah, New South Wales, Australia

Newcastle Private Hospital; 🇦🇺 New Lambton, New South Wales, Australia

Private Medical Suites; 🇦🇺 New Lambton, New South Wales, Australia