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

Intraoperative Complications Clinical Trial

— TAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296619
• Other study ID #: GaziosmanpashaU
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2014
• Last updated: February 25, 2016
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abdominal Hysterectomy (& Wertheim)
• Intraoperative Complications

Intervention

Procedure:
• 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
A sham band-aid will be applied to the abdomen of subjects

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University Hospital	Tokat	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of recovery	quality of recovery 40 form will use to assessment the recovery	postoperative 24 hours	No
Secondary	Postoperative nausea and vomiting	nausea score(0-3) and number of vomiting will be recorded	postoperative 0.,2.,12.,24 hours	No
Secondary	postoperative pain	visual analog scale will be used	postoperative 0,2,12,24 hours	No
Secondary	intraoperative hemodynamic variables	arterial blood pressure, heart rate changes will be recorded	during anaesthesia	No
Secondary	intraoperative anaesthetic consumption	anaesthetic consumption will be calculated	during anaesthesia	No