Transversus Abdominis Plane Block From Abdominal Approach

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

Detailed Description
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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.

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

Conditions
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Transversus Abdominis Plane Block From Abdominal Approach

Intervention / Treatment
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* Procedure: Transversus abdominis plane block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.5% Ropivacaine<br>group receiving TAP block (0.5% ropivacaine at TAP plane) | Procedure: Transversus abdominis plane block<br>* 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.<br>* Other names: TAP block;|
| Placebo Comparator: normal saline<br>group receiving placebo (saline) at TAP plane | Procedure: Transversus abdominis plane block<br>* 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.<br>* Other names: TAP block;|

What is the study measuring?
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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 |