Efficacy Study of Rectus Sheath Block to Control Postoperative Pain (UGRSB)

April 14, 2014 updated by: Ersel GULEC, Cukurova University

The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children

The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01130
        • Department of Anesthesiology, Cukurova University Faculty of Medicine

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

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I-II
  • 3-15 years of age children
  • Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

Exclusion Criteria:

  • ASA physical status III and above
  • Parents who did not consider to participate in the study
  • Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound guided rectus sheath block
Ultrasound guided rectus sheath block
Procedure: ultrasound guided rectus sheath block
the application of rectus sheath block with ultrasound guidance
Other Names:
  • US guided rectus sheath block
Active Comparator: iv morphine
0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period
Drug: Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the FLACC scale
Time Frame: Twenty-four hours
FLACC scale has been used to measure postoperative pain level in children
Twenty-four hours

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Dilek Ozcengiz, Prof., Department of Anesthesiology, Cukurova University Faculty of Medicine

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

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGRSB-123

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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