Transversus Abdominis Plane Block In Children

December 8, 2016 updated by: ILKE KUPELI, Erzincan University

Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study

Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • To undergo elective lower abdominal surgery
  • between 2-6 years old

Exclusion Criteria:

  • Patients with psychiatric disease
  • Patients whose weight is more than 40 kg
  • Patients with cardiac-pulmonary-neurological disease
  • Patients with bleeding disorder
  • Patients with infection or scar on the injection area
  • Patients with known allergies to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: control group
After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV
Drug: ketamine
ACTIVE_COMPARATOR: block and ketamine
Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia
Drug: ketamine
ACTIVE_COMPARATOR: ketamine atropine; laryngeal mask
After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block.
Drug: ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the amount of anesthetic drug which was used
Time Frame: two hour
two hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative visual analogue scale
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

December 4, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERZINCAN UNIVERSITY 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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