Ultrasound-guided Rectus Sheath Block In Children

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: rectus sheath block; Drug: Tramadol

• Registration Number: NCT02291705
• Lead Sponsor: Cukurova University

Brief Summary

Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.

Detailed Description

After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.

Primary end point was pain score using FLACC scale.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

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

Inclusion Criteria

• The children aged 2-7 years scheduled for inguinal hernia repair

Exclusion Criteria

• American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rectus sheath block	rectus sheath block	rectus sheath block
tramadol	Tramadol	tramadol control group

Primary Outcome Measures

Name	Time	Method
Pain Scores	postoperative 24 hours

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey