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

NCT ID: NCT05460442

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-07-29

Brief Summary

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.

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.

Conditions

Hip Surgery; Pericapsular Nerve; Fascia Iliaca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Caudal Block group

25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.

Group Type: EXPERIMENTAL

Caudal Block group

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Pericapsular nerve group block

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Fascia iliaca group

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elsaied Mohamed Hosny Alam

Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University hospitals

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Alam, M.B.B.CH

Role: CONTACT

ahmed161971_pg@med.tanta.edu.eg

1062612327 ext. +20

Facility Contacts

Ahmed Elsaied, M.B.B.CH

Role: primary

ahmed161971_pg@med.tanta.edu.eg

1062612327 ext. +20

Other Identifiers

35436/4/22

Identifier Type: -

Identifier Source: org_study_id