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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pericapsular Nerve Group Block
• Intervention / Treatment: Drug: Fentanyl; Procedure: Caudal epidural analgesia; Drug: Morphine; Drug: Acetaminophen; Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block; Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ramy m alkonaiesy; Phone Number: +2 01224883990; Email: ramyalkonaiesy@gmail.com
• Study Contact Backup: Name: Ahmed M Lotfy; Phone Number: +2 01000608905; Email: ahmed.lotfy@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals
    • Contact: Abul-Reesh children hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C; Patients will receive caudal analgesia	Drug: Fentanyl; 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).; Procedure: Caudal epidural analgesia; 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).; Drug: Morphine; 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; Drug: Acetaminophen; P atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours
Active Comparator: Group B; patients will receive PENG block and Lateral Femoral Cutaneous Nerve block	Drug: Fentanyl; 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).; Drug: Morphine; 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; Drug: Acetaminophen; P atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours; Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block; 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; Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	Time (minutes) to first need of rescue analgesia postoperative.	First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hemodynamic parameters	systolic, diastolic, mean blood pressure (mmHg)	intraoperative period
Intraoperative hemodynamic parameters	heart rate (bpm)	intraoperative period
Total fentanyl consumption	total intraoperative consumed fentanyl (mg/kg)	intraoperative period
Total morphine consumption	total postoperative consumed morphine (mg/kg)	First 24 hours postoperative
Postoperative pain assessment FLACC	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	First 24 hours postoperative

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hip surgery; Lateral Femoral Cutaneous Nerve Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Acetaminophen; Morphine
• Other Study ID Numbers: MD-16-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No