Transversus Abdominis Plane Block From Abdominal Approach

Not Applicable

• Conditions: Transversus Abdominis Plane Block From Abdominal Approach
• Interventions: Procedure: Transversus abdominis plane block

• Registration Number: NCT01144273
• Lead Sponsor: United Christian Hospital

Brief Summary

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

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 Timeline

• Study Start: 2010-05
• Status Verified: 2010-06
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30
• Primary Completion: 2010-10
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5% Ropivacaine	Transversus abdominis plane block	group receiving TAP block (0.5% ropivacaine at TAP plane)
normal saline	Transversus abdominis plane block	group receiving placebo (saline) at TAP plane

Primary Outcome Measures

Name	Time	Method
postoperative 24hr morphine consumption	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

Name	Time	Method
morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.	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	24hrs
incidence of nausea and vomiting	24hours postoperatively

Trial Locations

Locations (1)

Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital; 🇭🇰 Kwun Tong, Kowloon, Hong Kong