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

NCT00682136 | Completed Phase 1

• 2 other identifiers: TAPTRIAL08/02/20/3.02
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain

Keywords

postoperative analgesia; abdominal surgery; ropivacaine; local anaesthesia; tap block; pain management

Outcome Measures

Primary Outcomes (1)

• mg/kg of morphine equivalent used by patients post operatively.

  From operation until discharge.

Secondary Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: US-Guided Ropivacaine TAP Block

2

ACTIVE COMPARATOR

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

Procedure: US-Guided Ropivacaine TAP Block

Interventions

US-Guided Ropivacaine TAP Block PROCEDURE

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

Also known as: TAP Block

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hunter Colorectal Research: lead

Study Sites (4)

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Newcastle Private Hospital

New Lambton, New South Wales, 2305, Australia

Location

Private Medical Suites

New Lambton, New South Wales, 2305, Australia

Location

Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 3, 2010

Record last verified: 2010-06

Locations

AU (4)