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

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

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Ilioinguinal/iliohypogastric nerve blocks; Procedure: Erector spinae nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Enas A Abd el Motlb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Ilioinguinal/iliohypogastric nerve blocks; The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks	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
OTHER: Erector spinae nerve block; The patient will receive ultrasound-guided erector spinae nerve block	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Enas A Abd el Motlb, MD, Assistant Professor, Anesthesia Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ACTUAL): October 20, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 18, 2018
• First Posted (ACTUAL): August 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: R.18.05.202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No