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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ilioinguinal/iliohypogastric nerve blocks
Erector spinae nerve block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inguinal Hernia

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Enas A Abd el Motlb

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ilioinguinal/iliohypogastric nerve blocks

Erector spinae nerve block

Arm Description

The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks

The patient will receive ultrasound-guided erector spinae nerve block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to first analgesic request
Time to first analgesic request
number of patients requiring rescue analgesic
incidence of postoperative nausea and vomiting

Full Information

First Posted
August 18, 2018
Last Updated
March 25, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03640598
Brief Title
Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block in Children Undergoing Inguinal Surgeries
Official Title
Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilioinguinal/iliohypogastric nerve blocks
Arm Type
Other
Arm Description
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks
Arm Title
Erector spinae nerve block
Arm Type
Other
Arm Description
The patient will receive ultrasound-guided erector spinae nerve block
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal/iliohypogastric nerve blocks
Intervention Description
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate
Intervention Type
Procedure
Intervention Name(s)
Erector spinae nerve block
Intervention Description
The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.
Primary Outcome Measure Information:
Title
Postoperative CHEOPS scale
Description
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.
Time Frame
for 6 hours after surgery
Secondary Outcome Measure Information:
Title
Time to first analgesic request
Description
Time to first analgesic request
Time Frame
during first 24 hours
Title
number of patients requiring rescue analgesic
Time Frame
during first 24 hours
Title
incidence of postoperative nausea and vomiting
Time Frame
during first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas A Abd el Motlb, MD
Organizational Affiliation
Assistant Professor, Anesthesia Department
Official's Role
Study Chair
Facility Information:
Facility Name
Enas A Abd el Motlb
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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