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

This study has been completed.
Sponsor:
Information provided by:
Hunter Colorectal Research
ClinicalTrials.gov Identifier:
NCT00682136
First received: May 20, 2008
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Pain
Procedure: US-Guided Ropivacaine TAP Block
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Hunter Colorectal Research:

Primary Outcome Measures:
  • mg/kg of morphine equivalent used by patients post operatively. [ Time Frame: From operation until discharge. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung Function (spirometry), including FVC, FEV1 and PEFR [ Time Frame: 24, 48 and 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Visual Analogue Scale for pain at rest, deep breathing and coughing. [ Time Frame: 24, 48 and 72 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.
Procedure: US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
Other Name: TAP Block
Active Comparator: 2
Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.
Procedure: US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
Other Name: TAP Block

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682136

Locations
Australia, New South Wales
Private Medical Suites
New Lambton, New South Wales, Australia, 2305
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Newcastle Private Hospital
New Lambton, New South Wales, Australia, 2305
Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Sponsors and Collaborators
Hunter Colorectal Research
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Dr Brian Draganic, Hunter Colerectal Research
ClinicalTrials.gov Identifier: NCT00682136     History of Changes
Other Study ID Numbers: TAPTRIAL, 08/02/20/3.02
Study First Received: May 20, 2008
Last Updated: June 2, 2010
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Hunter Colorectal Research:
postoperative analgesia
abdominal surgery
ropivacaine
local anaesthesia
tap block
pain management

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014