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

NCT ID: NCT02296619

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-02-29

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.

Conditions

Abdominal Hysterectomy (& Wertheim); Intraoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

TAP block

Intervention Type: PROCEDURE

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 who are randomized to the no intervention group.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Control

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

Intervention Type: PROCEDURE

Other Intervention Names

Transversus abdominis plane block; sham group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Tuğba Karaman

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuğba Karaman, MD

Role: PRINCIPAL_INVESTIGATOR

GOU

Locations

Gaziosmanpasa University Hospital

Tokat Province, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpashaU

Identifier Type: -

Identifier Source: org_study_id