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Clinical Trials/NCT00682136
NCT00682136
Completed
Phase 1

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

Hunter Colorectal Research4 sites in 1 country206 target enrollmentApril 2008
ConditionsPain

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pain
Sponsor
Hunter Colorectal Research
Enrollment
206
Locations
4
Primary Endpoint
mg/kg of morphine equivalent used by patients post operatively.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
December 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hunter Colorectal Research

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: From operation until discharge.

Secondary Outcomes

  • 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 Sites (4)

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