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

K

Kasr El Aini Hospital

Status and phase

Enrolling
Phase 2

Conditions

Pericapsular Nerve Group Block

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06417268
MD-16-2024

Details and patient eligibility

About

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.

Full description

All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure.

General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane.

Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg.

After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.

Enrollment

68 estimated patients

Sex

All

Ages

1 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

Group C
Active Comparator group
Description:
Patients will receive caudal analgesia
Treatment:
Drug: Morphine
Drug: Acetaminophen
Drug: Fentanyl
Procedure: Caudal epidural analgesia
Group B
Active Comparator group
Description:
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
Treatment:
Drug: Morphine
Drug: Acetaminophen
Drug: Fentanyl
Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block
Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block

Trial contacts and locations

1

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Central trial contact

Ramy m alkonaiesy; Ahmed M Lotfy

Data sourced from clinicaltrials.gov

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