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

Phase 4

Completed

• Conditions: Intraoperative Complications; Abdominal Hysterectomy (& Wertheim)
• Interventions: Procedure: TAP block; Procedure: Control

• Registration Number: NCT02296619
• Lead Sponsor: Tokat Gaziosmanpasa University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-20
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block	TAP block	Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle
Control	Control	A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group.

Primary Outcome Measures

Name	Time	Method
intraoperative opioid consumption	during anaesthesia	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gaziosmanpasa University Hospital; 🇹🇷 Tokat, Merkez, Turkey