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Clinical Trials/NCT02115087
NCT02115087
Completed
Phase 4

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

Cukurova University1 site in 1 country40 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
ultrasound guided rectus sheath block
Conditions
Pain, Postoperative
Sponsor
Cukurova University
Enrollment
40
Locations
1
Primary Endpoint
Pain Scores on the FLACC scale
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
January 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ersel GULEC

Assist.Prof.

Cukurova University

Eligibility Criteria

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

Arms & Interventions

ultrasound guided rectus sheath block

Ultrasound guided rectus sheath block

Intervention: ultrasound guided rectus sheath block

iv morphine

0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period

Intervention: Morphine

Outcomes

Primary Outcomes

Pain Scores on the FLACC scale

Time Frame: Twenty-four hours

FLACC scale has been used to measure postoperative pain level in children

Study Sites (1)

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