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

NCT03640598 | Completed DMC

• 1 other identifier: R.18.05.202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Ilioinguinal/iliohypogastric nerve blocks

OTHER

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

Procedure: Ilioinguinal/iliohypogastric nerve blocks

Erector spinae nerve block

OTHER

The patient will receive ultrasound-guided erector spinae nerve block

Procedure: Erector spinae nerve block

Interventions

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

Ilioinguinal/iliohypogastric nerve blocks

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.

Erector spinae nerve block

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• : American Society of Anesthesiologists physical status I - II

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Enas A Abd el Motlb

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Officials

• Enas A Abd el Motlb, MD

  Assistant Professor, Anesthesia Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 21, 2018
• Study Start: August 20, 2018
• Primary Completion: October 20, 2018
• Study Completion: November 1, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

EG (1)