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

NCT ID: NCT03640598

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2018-11-01

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.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ilioinguinal/iliohypogastric nerve blocks

The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks

Group Type: OTHER

Ilioinguinal/iliohypogastric nerve blocks

Intervention Type: PROCEDURE

The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate

Erector spinae nerve block

The patient will receive ultrasound-guided erector spinae nerve block

Group Type: OTHER

Erector spinae nerve block

Intervention Type: PROCEDURE

The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.

Interventions

Ilioinguinal/iliohypogastric nerve blocks

The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate

Intervention Type: PROCEDURE

Erector spinae nerve block

The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enas A Abd el Motlb, MD

Role: STUDY_CHAIR

Assistant Professor, Anesthesia Department

Locations

Enas A Abd el Motlb

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R.18.05.202

Identifier Type: -

Identifier Source: org_study_id