The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy (TAP)
Primary Purpose
Abdominal Hysterectomy (& Wertheim), Intraoperative Complications
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
TAP block
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Abdominal Hysterectomy (& Wertheim)
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
Sites / Locations
- Gaziosmanpasa University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TAP Block
Control
Arm Description
Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle
A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of recovery
quality of recovery 40 form will use to assessment the recovery
Postoperative nausea and vomiting
nausea score(0-3) and number of vomiting will be recorded
postoperative pain
visual analog scale will be used
intraoperative hemodynamic variables
arterial blood pressure, heart rate changes will be recorded
intraoperative anaesthetic consumption
anaesthetic consumption will be calculated
Full Information
NCT ID
NCT02296619
First Posted
November 13, 2014
Last Updated
February 25, 2016
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT02296619
Brief Title
The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hysterectomy (& Wertheim), Intraoperative Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP Block
Arm Type
Experimental
Arm Description
Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus abdominis plane block
Intervention Description
Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
sham group
Intervention Description
A sham band-aid will be applied to the abdomen of subjects
Primary Outcome Measure Information:
Title
intraoperative opioid consumption
Description
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.
Time Frame
during anaesthesia
Secondary Outcome Measure Information:
Title
Quality of recovery
Description
quality of recovery 40 form will use to assessment the recovery
Time Frame
postoperative 24 hours
Title
Postoperative nausea and vomiting
Description
nausea score(0-3) and number of vomiting will be recorded
Time Frame
postoperative 0.,2.,12.,24 hours
Title
postoperative pain
Description
visual analog scale will be used
Time Frame
postoperative 0,2,12,24 hours
Title
intraoperative hemodynamic variables
Description
arterial blood pressure, heart rate changes will be recorded
Time Frame
during anaesthesia
Title
intraoperative anaesthetic consumption
Description
anaesthetic consumption will be calculated
Time Frame
during anaesthesia
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba Karaman, MD
Organizational Affiliation
GOU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa University Hospital
City
Tokat
State/Province
Merkez
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
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The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy
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