Efficacy Study of Rectus Sheath Block to Control Postoperative Pain

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: ultrasound guided rectus sheath block; Drug: Morphine

• Registration Number: NCT02115087
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ultrasound guided rectus sheath block	ultrasound guided rectus sheath block	Ultrasound guided rectus sheath block
iv morphine	Morphine	0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period

Primary Outcome Measures

Name	Time	Method
Pain Scores on the FLACC scale	Twenty-four hours	FLACC scale has been used to measure postoperative pain level in children

Trial Locations

Locations (1)

Department of Anesthesiology, Cukurova University Faculty of Medicine; 🇹🇷 Adana, Turkey