Clinical trial NCT02296619: The Effects of Transversus Abdominis Plane Block 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Hysterectomy (& Wertheim)
Intraoperative Complications
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: intraoperative opioid consumption
timeFrame: during anaesthesia
Secondary outcomes:
measure: Quality of recovery
timeFrame: postoperative 24 hours
measure: Postoperative nausea and vomiting
timeFrame: postoperative 0.,2.,12.,24 hours
measure: postoperative pain
timeFrame: postoperative 0,2,12,24 hours
measure: intraoperative hemodynamic variables
timeFrame: during anaesthesia
measure: intraoperative anaesthetic consumption
timeFrame: during anaesthesia
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Hospital
state: Merkez
Study officials:
affiliation: GOU
name: Tuğba Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References: