Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block in Children Undergoing Inguinal Surgeries

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Ilioinguinal/iliohypogastric nerve blocks; Procedure: Erector spinae nerve block

• Registration Number: NCT03640598
• Lead Sponsor: Mansoura University

Brief Summary

Investigators aim to compare the efficacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia

Detailed Description

regarding patient registry; a prior G power analysis was done. 24 per group was determined to achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25 patients were included per group to replace any dropouts.

- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-08-18
• Study Start: 2018-08-20
• Study First Posted: 2018-08-21
• Primary Completion: 2018-10-20
• Study Completion: 2018-11-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• : American Society of Anesthesiologists physical status I - II

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Exclusion Criteria

• History of clinically significant cardiac disease.
• History of clinically significant hepatic disease.
• History of clinically significant renal disease.
• History of clinically significant neurological disease.
• Known allergy to local anaesthetics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ilioinguinal/iliohypogastric nerve blocks	Ilioinguinal/iliohypogastric nerve blocks	The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks
Erector spinae nerve block	Erector spinae nerve block	The patient will receive ultrasound-guided erector spinae nerve block

Primary Outcome Measures

Name	Time	Method
Postoperative CHEOPS scale	for 6 hours after surgery	The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain).; When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.

Secondary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	during first 24 hours
number of patients requiring rescue analgesic	during first 24 hours
Time to first analgesic request	during first 24 hours	Time to first analgesic request

Trial Locations

Locations (1)

Enas A Abd el Motlb; 🇪🇬 Mansoura, DK, Egypt