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Transversus Abdominis Plane Block From Abdominal Approach

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by United Christian Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United Christian Hospital
ClinicalTrials.gov Identifier:
NCT01144273
First received: June 14, 2010
Last updated: June 29, 2010
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by United Christian Hospital:

Primary Outcome Measures:
  • postoperative 24hr morphine consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 24hours postoperatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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
Study First Received: June 14, 2010
Last Updated: June 29, 2010
Health Authority: Hong Kong: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014