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Transversus Abdominis Plane Block From Abdominal Approach

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by United Christian Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144273
First Posted: June 15, 2010
Last Update Posted: June 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United Christian Hospital
  Purpose
Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.

Condition Intervention
Transversus Abdominis Plane Block From Abdominal Approach Procedure: Transversus abdominis plane block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial

Further study details as provided by United Christian Hospital:

Primary Outcome Measures:
  • postoperative 24hr morphine consumption [ Time Frame: 24 hours ]
    The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.


Secondary Outcome Measures:
  • morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after. [ Time Frame: 24hrs ]
    • Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.

  • Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough [ Time Frame: 24hrs ]
  • incidence of nausea and vomiting [ Time Frame: 24hours postoperatively ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.5% Ropivacaine
group receiving TAP block (0.5% ropivacaine at TAP plane)
Procedure: Transversus abdominis plane block

This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now.

To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique.

Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer.

After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.

Other Name: TAP block
Placebo Comparator: normal saline
group receiving placebo (saline) at TAP plane
Procedure: Transversus abdominis plane block

This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now.

To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique.

Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer.

After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.

Other Name: TAP block

Detailed Description:
Potential advantages compared to percutaneous approach are decrease in risk of visceral injury as it is under direct visual and tactile guidance, ease of approach in obese patients, short theatre time for administration, easy to administer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III
  • Age 18 or above
  • Scheduled to undergo TAH+/- salpingoophorectomy.
  • Scheduled to receive general anaesthesia under standardized anaesthetic regime.
  • Comprehends how to use intravenous patient controlled analgesia (IV PCA).
  • Is willing to complete the postoperative assessment.
  • Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.

Exclusion Criteria:

  • Known allergy to drugs involved in this study
  • Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
  • Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
  • With co-existing pathology resulting in persistent pain requiring analgesics.
  • Wound incision extending to supra-umbilical level.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144273


Contacts
Contact: Wing Yee Lillian Choy, MBBS (HK) 3513 4245 cwy027@ha.org.hk

Locations
Hong Kong
Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital Recruiting
Kwun Tong, Kowloon, Hong Kong
Contact: Wing Yee Lillian Choy, MBBS (HK)    3513 4245      
Principal Investigator: Wing Yee Lillian Choy, MBBS (HK)         
Sub-Investigator: Huey Sing Lim, FANZCA,FHKCA         
Sub-Investigator: Man Shun Law, FHKCA,FHKAM         
Sponsors and Collaborators
United Christian Hospital
Investigators
Principal Investigator: Wing Yee Lillian Choy, MBBS (HK) United Christian Hospital, Hospital Authority
  More Information

Publications:
Responsible Party: Dr Choy Wing Yee Lillian, United Christian Hospital, Hospital Authority
ClinicalTrials.gov Identifier: NCT01144273     History of Changes
Other Study ID Numbers: Protocol ver 1.1
KC/KE-10-0021/FR-3 ( Other Identifier: Research Ethics committee (Kowloon Central/Kowloon East) )
First Submitted: June 14, 2010
First Posted: June 15, 2010
Last Update Posted: June 30, 2010
Last Verified: June 2010

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