Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery - Full Text View

Sponsored by:	Hunter Colorectal Research
Information provided by:	Hunter Colorectal Research
ClinicalTrials.gov Identifier:	NCT00682136

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 I

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Ropivacaine Ropivacaine monohydrochloride Ropivacaine Hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery

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
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
2: Active Comparator 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.

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

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

Contacts

Contact: Brian Draganic, B.Med., F.R.A.C.S	61-24-956-3243	brian@bdss.com.au
Contact: Stephen Smith, B.Med., F.R.A.C.S.	61-24-956-3243	Stephen.Smith@hnehealth.nsw.gov.au

Locations

Australia, New South Wales
Private Medical Suites	Recruiting
New Lambton, New South Wales, Australia, 2305
Contact: Brian Draganic, B.Med.,B.Med.Sci(Hons),FRACS 61-24-956-3243 brian@bdss.com.au
Contact: Stepehen Smith, B.Med, FRACS 61-24-956-3243 Stephen.Smith@hnehealth.nsw.gov.au
Principal Investigator: Andrew Williams
John Hunter Hospital	Recruiting
New Lambton, New South Wales, Australia, 2305
Contact: Steven Deane 61-24-921-3000
Principal Investigator: Andrew Williams
Newcastle Private Hospital	Recruiting
New Lambton, New South Wales, Australia, 2305
Contact: Michelle Barnett 61-24-941-8482 michelle.barnett@healthscope.com.au
Principal Investigator: Andrew Williams
Mater Misericordiae Hospital	Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Stephen Smith 61-24-956-3243 Stephen.Smith@hnehealth.nsw.gov.au
Principal Investigator: Andrew Williams

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:	Hunter Colerectal Research ( Dr Brian Draganic )
Study ID Numbers:	TAPTRIAL, 08/02/20/3.02
Study First Received:	May 20, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00682136 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Hunter Colorectal Research:

postoperative analgesia
abdominal surgery
ropivacaine

local anaesthesia
tap block
pain management

Study placed in the following topic categories:

Ropivacaine
Central Nervous System Depressants
Anesthetics
Pain

Peripheral Nervous System Agents
Analgesics
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Ropivacaine
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009