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Completed

NCT Number: NCT06417268

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

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.

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Key information

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

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.

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).

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.

Other names: rescue analgesia

Acetaminophen

Drug

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

Primary outcomes

  1. Time to first rescue analgesia

    Time frame: First 24 hours postoperative

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

Secondary outcomes

  1. Intraoperative hemodynamic parameters

    Time frame: intraoperative period

    systolic, diastolic, mean blood pressure (mmHg)

  2. Intraoperative hemodynamic parameters

    Time frame: intraoperative period

    heart rate (bpm)

  3. Total fentanyl consumption

    Time frame: intraoperative period

    total intraoperative consumed fentanyl (mg/kg)

  4. Total morphine consumption

    Time frame: First 24 hours postoperative

    total postoperative consumed morphine (mg/kg)

  5. Postoperative pain assessment FLACC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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