Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative CHEOPS scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ilioinguinal/iliohypogastric nerve blocks
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks
Intervention: Ilioinguinal/iliohypogastric nerve blocks (Procedure)
Erector spinae nerve block
The patient will receive ultrasound-guided erector spinae nerve block
Intervention: Erector spinae nerve block (Procedure)
Outcomes
Primary Outcomes
Postoperative CHEOPS scale
Time Frame: 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 Outcomes
- 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)