Ultrasound-guided Rectus Sheath Block In Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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rectus sheath block

Group Type EXPERIMENTAL

rectus sheath block

Intervention Type PROCEDURE

ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine

tramadol

tramadol control group

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

tramadol 1 mg/kg iv

Interventions

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rectus sheath block

ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine

Intervention Type PROCEDURE

Tramadol

tramadol 1 mg/kg iv

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes