Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pediatric Hip Surgery

NCT05460442 | Unknown

• 1 other identifier: 35436/4/22
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.

Conditions

Hip Surgery; Pericapsular Nerve; Fascia Iliaca

Outcome Measures

Primary Outcomes (1)

• Total Opioids consumption

  Total Opioids consumption in first 24 hour postoperatively will be recorded

  24 hours postoperatively

Secondary Outcomes (5)

• Postoperative pain

  At post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.

• Time to first rescue analgesia

  24 hours Postoperatively

• Adverse effects

  24 hours Postoperatively

• Heart rate

  Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours

• Mean arterial blood pressure

  Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.

Study Arms (3)

Caudal Block group

EXPERIMENTAL

25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.

Procedure: Caudal Block group

Pericapsular nerve group block

EXPERIMENTAL

25 patients will receive ipsilateral ultrasound-guided Pericapsular nerve group block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.

Procedure: Pericapsular nerve group block

Fascia iliaca group

EXPERIMENTAL

25 patients will receive ipsilateral ultrasound-guided Fascia iliaca compartment block with bupivacaine 0.25% (0.5 m. L/kg) after induction of anesthesia.

Procedure: Fascia iliaca group

Interventions

Caudal Block group PROCEDURE

Patients will be placed in the lateral decubitus position. After local sterilization with povidone-iodine, the sacral hiatus will be visualized at the level of the sacral Cornus by ultrasound. The needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute

Caudal Block group

Pericapsular nerve group block PROCEDURE

Patients will receive ultrasound-guided Pericapsular nerve group block in the supine position after proper sterilization of the groin region. The needle will be inserted in-plane with the transducer. The Pericapsular nerve group block group will receive 0.5 mL/kg of (0.25%) bupivacaine after a negative aspiration

Pericapsular nerve group block

Fascia iliaca group PROCEDURE

Patients will receive Ultrasound-Guided fascia iliaca compartment block in the supine position after sterilization of groin area. The needle will be inserted in-plane with the transducer. The needle tip will be advanced through the fascia iliaca and inserted further cephalad just below the fascia iliaca into the iliacus muscle. 0.5 mL/kg of (0.25%) bupivacaine will be injected and visualized moving cephalad away from the needle tip

Fascia iliaca group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients
• aged 1-6 years old
• both sexes,
• American Society of Anesthesiologists (ASA) physical activity class I-II
• scheduled for elective hip surgery under general anesthesia.

You may not qualify if:

• Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.
• Children with previous neurological or spinal disorders.
• Coagulation disorder.
• Infection at the block injection site.
• History of allergy to local anesthetics.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, Egypt

RECRUITING

Central Study Contacts

Ahmed Alam, M.B.B.CH

CONTACT

1062612327; ahmed161971_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: July 15, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 29, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)