NCT02296619

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

November 13, 2014

Last Update Submit

February 25, 2016

Conditions

Abdominal Hysterectomy (& Wertheim)Intraoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of recovery

    postoperative 24 hours

  • Postoperative nausea and vomiting

    postoperative 0.,2.,12.,24 hours

  • postoperative pain

    postoperative 0,2,12,24 hours

  • intraoperative hemodynamic variables

    during anaesthesia

  • intraoperative anaesthetic consumption

    during anaesthesia

Study Arms (2)

TAP Block

EXPERIMENTAL

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

Control

SHAM COMPARATOR

A sham band-aid will be applied to the abdomen of subjects who are randomized to the no intervention group.

Procedure: Control

Interventions

TAP blockPROCEDURE

Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle

Also known as: Transversus abdominis plane block
TAP Block
ControlPROCEDURE

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

Also known as: sham group
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18-65years old)
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Patients scheduled for elective total abdominal hysterectomy under general anesthesia

You may not qualify if:

  • ASA physical status ≥ 3
  • Allergy to local anesthetics
  • Drug abuse or addiction
  • Bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tuğba Karaman, MD

    GOU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 20, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

TU(1)