Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries

NCT06417268 | Recruiting Phase 2

• 1 other identifier: MD-16-2024
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.

Conditions

Pericapsular Nerve Group Block

Keywords

Hip surgery; Lateral Femoral Cutaneous Nerve Block

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  Time (minutes) to first need of rescue analgesia postoperative.

  First 24 hours postoperative

Secondary Outcomes (5)

• Intraoperative hemodynamic parameters

  intraoperative period

• Intraoperative hemodynamic parameters

  intraoperative period

• Total fentanyl consumption

  intraoperative period

• Total morphine consumption

  First 24 hours postoperative

• Postoperative pain assessment FLACC

  First 24 hours postoperative

Study Arms (2)

Group C

ACTIVE COMPARATOR

Patients will receive caudal analgesia

Procedure: Caudal epidural analgesia; Drug: Fentanyl; Drug: Morphine; Drug: Acetaminophen

Group B

ACTIVE COMPARATOR

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block; Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block; Drug: Fentanyl; Drug: Morphine; Drug: Acetaminophen

Interventions

Caudal epidural analgesia PROCEDURE

patient will be placed in the left lateral position with flexed hips.After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture is performed in the most proximal region of the sacral hiatus with the needle inclined 45-60° to the skin. While palpating with the index finger of the left hand, the needle is inserted immediately below the spinous process S4. After perforating the membrane, the needle will be advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection, The confirmation of the correct position of the caudal needle before injection by performing the modified 'swoosh' test" performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of saline. Bupivacaine 0.25% at a dose of 1 ml/kg will be injected, with care taken not to exceed the maximum recommended dose (2 mg/kg).

Group C

Ultrasound-guided Combined Pericapsular Nerve Group Block PROCEDURE

With supine position, the probe will be put in a transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral nerve, and femoral artery (FA). Then the probe will be rotated counter clockwise to align with the pubic ramus to visualize the AIIS, iliopsoas prominence (IPE), FA, iliopsoas, and iliopsoas notch. Under direct vision, a 22-gauge, 50-mm echo needle will be advanced in the lateral-medial plane between the psoas tendon and the pubic ramus until the needle tip touches the IPE. The needle will be withdrawn, and after negative aspiration, 1 ml/kg (Bupivacaine 0.25%) is injected

Group B

Ultrasound-guided Lateral Femoral Cutaneous Nerve Block PROCEDURE

patient remains supine, and the transducer is parallel to the inguinal ligament. With the femoral artery and vein as guidance, the lateral part of the sartorius muscle and fascia lata is visualized. Approximately 3 cm inferior from this point, the branches of the lateral femoral cutaneous nerve are visualized in the hypoechoic fat-filled subfascial space between the sartorius muscle medially and the tensor fascia lata muscle laterally. A 22-gauge, 50-mm needle is inserted with in plane approach at a shallow angle to reach the area of the nerve and after negative aspiration, 0.1 ml/kg (Bupivacaine 0.25%) is injected.

Group B

Fentanyl DRUG

patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).

Group B; Group C

Morphine DRUG

If a FLACC pain Score is ≥ 4/10, the patient in the PACU will receive morphine (intravenous, 0.03 mg/kg), and the maximum allowed dose is 0.1mg/kg every 4 hours.

Also known as: rescue analgesia

Group B; Group C

Acetaminophen DRUG

P atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours

Group B; Group C

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I, II.
• Unilateral hip surgery.

You may not qualify if:

• Parents' refusal to participate in the study.
• Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5).
• Localized infection at the site of needle insertion.
• Known hypersensitivity or allergies to any of the used drugs.
• Bilateral hip surgery in the same session.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl; Morphine; Acetaminophen

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ramy m alkonaiesy

CONTACT

01224883990; ramyalkonaiesy@gmail.com

Ahmed M Lotfy

CONTACT

01000608905; ahmed.lotfy@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: May 16, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)