Transversus Abdominis Plane Block From Abdominal Approach

Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial

Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.

Study Overview

• Status: Unknown
• Conditions: Transversus Abdominis Plane Block From Abdominal Approach
• Intervention / Treatment: Procedure: Transversus abdominis plane 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative 24hr morphine consumption	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.	• Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.	24hrs
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		24hrs
incidence of nausea and vomiting		24hours postoperatively

Collaborators and Investigators

• Sponsor: United Christian Hospital
• Investigators: Principal Investigator: Wing Yee Lillian Choy, MBBS (HK), United Christian Hospital, Hospital Authority

Publications and helpful links

General Publications

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
• Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 30, 2010
• Last Update Submitted That Met QC Criteria: June 29, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: Protocol ver 1.1; KC/KE-10-0021/FR-3 (Other Identifier: Research Ethics committee (Kowloon Central/Kowloon East))