Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pediatric Hip Surgery

Comparison of Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Fascia Iliaca Block for Pediatric Hip Surgery

This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.

Study Overview

• Status: Recruiting
• Conditions: Hip Surgery; Pericapsular Nerve; Fascia Iliaca
• Intervention / Treatment: Procedure: Caudal Block group; Procedure: Pericapsular nerve group block; Procedure: Fascia iliaca group

Detailed Description

Surgeries involving hip joints in pediatric patients are associated with severe intraoperative and postoperative pain despite the use of systemic opioids.

Caudal block is the most commonly used method of regional anesthesia in children to control intraoperative and postoperative pain in surgeries involving lower limbs. However, there have been many side effects of caudal block such as hypotension, urine retention, excessive motor block, technical failure, nausea, and vomiting which may limit its use.

There are several techniques of ultrasound-guided regional anesthesia that are used to control acute pain in hip surgery with fewer side effects such as a lumbar plexus block, femoral nerve block, or a fascia iliaca compartment block.

The fascia iliaca compartment block (FICB) was described in 1989. It remains a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Local anesthetic (LA) is injected proximally beneath the fascia iliaca to block the femoral nerve (FN), obturator nerve (ON), and lateral cutaneous nerve of the thigh (LCNT) simultaneously.

The pericapsular nerve group (PENG) block was introduced to block the articular branches of the femoral, obturator, and accessory obturator nerves which provide sensory innervation to the hip. This regional anesthetic technique was described in 2018 for acute analgesia related to hip fractures.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Alam, M.B.B.CH; Phone Number: +20 1062612327; Email: ahmed161971_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanta University Hospitals
    • Contact: Ahmed Elsaied, M.B.B.CH; Phone Number: +20 1062612327; Email: ahmed161971_pg@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pediatric patients
• aged 1-6 years old
• both sexes,
• American Society of Anesthesiologists (ASA) physical activity class I-II
• scheduled for elective hip surgery under general anesthesia.

Exclusion Criteria:

• Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.
• Children with previous neurological or spinal disorders.
• Coagulation disorder.
• Infection at the block injection site.
• History of allergy to local anesthetics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caudal Block group; 25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.	Procedure: Caudal Block group; Patients will be placed in the lateral decubitus position. After local sterilization with povidone-iodine, the sacral hiatus will be visualized at the level of the sacral Cornus by ultrasound. The needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute
Experimental: Pericapsular nerve group block; 25 patients will receive ipsilateral ultrasound-guided Pericapsular nerve group block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.	Procedure: Pericapsular nerve group block; Patients will receive ultrasound-guided Pericapsular nerve group block in the supine position after proper sterilization of the groin region. The needle will be inserted in-plane with the transducer. The Pericapsular nerve group block group will receive 0.5 mL/kg of (0.25%) bupivacaine after a negative aspiration
Experimental: Fascia iliaca group; 25 patients will receive ipsilateral ultrasound-guided Fascia iliaca compartment block with bupivacaine 0.25% (0.5 m. L/kg) after induction of anesthesia.	Procedure: Fascia iliaca group; Patients will receive Ultrasound-Guided fascia iliaca compartment block in the supine position after sterilization of groin area. The needle will be inserted in-plane with the transducer. The needle tip will be advanced through the fascia iliaca and inserted further cephalad just below the fascia iliaca into the iliacus muscle. 0.5 mL/kg of (0.25%) bupivacaine will be injected and visualized moving cephalad away from the needle tip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioids consumption	Total Opioids consumption in first 24 hour postoperatively will be recorded	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain which will be assessed by face, legs, activity, and cry consolability scale [FLACC]	At post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.
Time to first rescue analgesia	Time of administration of first rescue analgesia will be recorded.	24 hours Postoperatively
Adverse effects	Adverse effects: hypotension, Bradycardia, hematoma, and local anesthetic toxicity will be observed and treated accordingly.	24 hours Postoperatively
Heart rate	Perioperative heart rate will be observed	Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours
Mean arterial blood pressure	Perioperative mean arterial blood pressure will be observed	Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): July 20, 2023
• Study Completion (Anticipated): July 29, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 35436/4/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available under a reasonable request from the corresponding author
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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