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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Ilioinguinal/iliohypogastric nerve blocks
* Procedure: Erector spinae nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: : American Society of Anesthesiologists physical status I - II 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ilioinguinal/iliohypogastric nerve blocks<br>The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks | Procedure: Ilioinguinal/iliohypogastric nerve blocks<br>* The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate<br>|
| Other: Erector spinae nerve block<br>The patient will receive ultrasound-guided erector spinae nerve block | Procedure: Erector spinae nerve block<br>* The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative CHEOPS scale | 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. | for 6 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request | Time to first analgesic request | during first 24 hours | 
| number of patients requiring rescue analgesic |  | during first 24 hours | 
| incidence of postoperative nausea and vomiting |  | during first 24 hours |