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

M

Mansoura University

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: Erector spinae nerve block
Procedure: Ilioinguinal/iliohypogastric nerve blocks

Study type

Interventional

Funder types

Other

Identifiers

NCT03640598
R.18.05.202

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Ilioinguinal/iliohypogastric nerve blocks
Other group
Description:
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks
Treatment:
Procedure: Ilioinguinal/iliohypogastric nerve blocks
Erector spinae nerve block
Other group
Description:
The patient will receive ultrasound-guided erector spinae nerve block
Treatment:
Procedure: Erector spinae nerve block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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