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Completed

NCT Number: NCT02296619

The Effects of Transversus Abdominis Plane Block 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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gaziosmanpasa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block

Procedure

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

Control

Procedure

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

Other names: sham group

Primary outcomes

  1. intraoperative opioid consumption

    Time frame: 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 outcomes

  1. Quality of recovery

    Time frame: postoperative 24 hours

    quality of recovery 40 form will use to assessment the recovery

  2. Postoperative nausea and vomiting

    Time frame: postoperative 0.,2.,12.,24 hours

    nausea score(0-3) and number of vomiting will be recorded

  3. postoperative pain

    Time frame: postoperative 0,2,12,24 hours

    visual analog scale will be used

  4. intraoperative hemodynamic variables

    Time frame: during anaesthesia

    arterial blood pressure, heart rate changes will be recorded

  5. intraoperative anaesthetic consumption

    Time frame: during anaesthesia

    anaesthetic consumption will be calculated

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Acronym: TAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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