The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of Transversus Abdominis Plane Block on hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in patients undergoing total abdominal hysterectomy

Detailed Description
-----------------
Pain is one of the main causes of the poor perioperative outcomes and pain management is the important part of perioperative period. Neuraxial blocks could provide adequate analgesia during and after abdominal surgery. However,neuraxial blocks have a lot of contraindicated situations and neuraxial anesthesia can easily induce hemodynamic abnormalities. Therefore, in most cases, the choice of anaesthetic management may be the general anesthesia. In addition to reduce the blood pressure and heart rate changes due to surgical stimulations, the large amount of opioids and anaesthetics may be required. Opioid related side effects can affect perioperative complications and postoperative quality of recovery. Transversus abdominis plane block is a new choice to reduce postoperative pain in abdominal surgery. Although its postoperative analgesic efficacy is well known, its effects on hemodynamic variables, anaesthetic and analgesic requirement is not clear. The main objective of this study is to estimate the effect of Transversus abdominis plane block on hemodynamic variables, anaesthetic and analgesic requirement and quality of recovery in patients undergoing total abdominal hysterectomy.

Official Title
-----------------
The Effects of TAP Block on Hemodynamic Variables, Anaesthetic and Analgesic Requirement and Quality of Recovery in Patients Undergoing Total Abdominal Hysterectomy

Conditions
-----------------
Abdominal Hysterectomy (& Wertheim), Intraoperative Complications

Intervention / Treatment
-----------------
* Procedure: TAP block
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18-65years old) American Society of Anesthesiologists (ASA) physical status I-II Patients scheduled for elective total abdominal hysterectomy under general anesthesia Exclusion Criteria: ASA physical status ≥ 3 Allergy to local anesthetics Drug abuse or addiction Bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block<br>Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle | Procedure: TAP block<br>* Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle<br>* Other names: Transversus abdominis plane block;|
| Sham Comparator: Control<br>A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group. | Procedure: Control<br>* A sham band-aid will be applied to the abdomen of subjects<br>* Other names: sham group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative opioid consumption | The overall intravenous remifentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer remifentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level. | during anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | quality of recovery 40 form will use to assessment the recovery | postoperative 24 hours | 
| Postoperative nausea and vomiting | nausea score(0-3) and number of vomiting will be recorded | postoperative 0.,2.,12.,24 hours | 
| postoperative pain | visual analog scale will be used | postoperative 0,2,12,24 hours | 
| intraoperative hemodynamic variables | arterial blood pressure, heart rate changes will be recorded | during anaesthesia | 
| intraoperative anaesthetic consumption | anaesthetic consumption will be calculated | during anaesthesia |