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

Phase 2

Recruiting

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

• Registration Number: NCT06417268
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-20
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-11
• Last Update Submitted: 2024-05-11
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ultrasound-guided Combined Pericapsular Nerve Group Block	patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
Group C	Caudal epidural analgesia	Patients will receive caudal analgesia
Group B	Ultrasound-guided Lateral Femoral Cutaneous Nerve Block	patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
Group C	Fentanyl	Patients will receive caudal analgesia
Group C	Morphine	Patients will receive caudal analgesia
Group C	Acetaminophen	Patients will receive caudal analgesia
Group B	Fentanyl	patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
Group B	Morphine	patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
Group B	Acetaminophen	patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	First 24 hours postoperative	Time (minutes) to first need of rescue analgesia postoperative.

Secondary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic parameters	intraoperative period	heart rate (bpm)
Total fentanyl consumption	intraoperative period	total intraoperative consumed fentanyl (mg/kg)
Total morphine consumption	First 24 hours postoperative	total postoperative consumed morphine (mg/kg)
Postoperative pain assessment FLACC	First 24 hours postoperative	In the PACU, quality of analgesia was assessed every 15 minutes for the first hour then after 2, 4 ,6 ,12,18 and 24 hours postoperative using (face, legs, activity, and cry consolability scale) (FLACC) pain score

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt