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Completed

NCT Number: NCT03640598

Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block 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

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enas A Abd el Motlb

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ilioinguinal/iliohypogastric nerve blocks

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

Procedure

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

Primary outcomes

  1. 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

  1. Time to first analgesic request

    Time frame: during first 24 hours

    Time to first analgesic request

  2. number of patients requiring rescue analgesic

    Time frame: during first 24 hours

  3. incidence of postoperative nausea and vomiting

    Time frame: during first 24 hours

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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