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

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

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

Study Overview

• Status: Completed
• Conditions: Intraoperative Complications; Abdominal Hysterectomy (& Wertheim)
• Intervention / Treatment: Procedure: TAP block; Procedure: Control

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Tokat, Merkez, Turkey, 60100
      • Gaziosmanpasa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Transversus abdominis plane block
Sham Comparator: Control; A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group.	Procedure: Control; A sham band-aid will be applied to the abdomen of subjects; 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

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Tuğba Karaman, MD, GOU

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications
• Other Study ID Numbers: GaziosmanpashaU