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

Hip Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460442
• Other study ID #: 35436/4/22
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 29, 2023

Study information

• Verified date: July 2022
• Source: Tanta University
• Contact: Ahmed Alam, M.B.B.CH
• Phone: 1062612327
• Email: ahmed161971_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 29, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Surgery

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Egypt	Tanta University hospitals	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioids consumption	Total Opioids consumption in first 24 hour postoperatively will be recorded	24 hours postoperatively
Secondary	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.
Secondary	Time to first rescue analgesia	Time of administration of first rescue analgesia will be recorded.	24 hours Postoperatively
Secondary	Adverse effects	Adverse effects: hypotension, Bradycardia, hematoma, and local anesthetic toxicity will be observed and treated accordingly.	24 hours Postoperatively
Secondary	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
Secondary	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.