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Completed

NCT Number: NCT00682136

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

John Hunter Hospital, New Lambton, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

US-Guided Ropivacaine TAP Block

Procedure

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

Other names: TAP Block

Primary outcomes

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

    Time frame: From operation until discharge.

Secondary outcomes

  1. Lung Function (spirometry), including FVC, FEV1 and PEFR

    Time frame: 24, 48 and 72 hours postoperatively

  2. Visual Analogue Scale for pain at rest, deep breathing and coughing.

    Time frame: 24, 48 and 72 hours postoperatively

Sponsors and collaborators

Lead sponsor

Hunter Colorectal Research

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 22, 2008
Registry last updated
Jun 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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