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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682136
• Other study ID #: TAPTRIAL
• Secondary ID: 08/02/20/3.02
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2008
• Last updated: June 2, 2010
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: Hunter Colorectal Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.

Locations

Country	Name	City	State
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	Newcastle Private Hospital	New Lambton	New South Wales
Australia	Private Medical Suites	New Lambton	New South Wales
Australia	Mater Misericordiae Hospital	Waratah	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Colorectal Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mg/kg of morphine equivalent used by patients post operatively.		From operation until discharge.	No
Secondary	Lung Function (spirometry), including FVC, FEV1 and PEFR		24, 48 and 72 hours postoperatively	No
Secondary	Visual Analogue Scale for pain at rest, deep breathing and coughing.		24, 48 and 72 hours postoperatively	No