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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640598
• Other study ID #: R.18.05.202
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: March 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Enas A Abd el Motlb	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first analgesic request	Time to first analgesic request	during first 24 hours
Secondary	number of patients requiring rescue analgesic		during first 24 hours
Secondary	incidence of postoperative nausea and vomiting		during first 24 hours