PENG Block in Comparison With FICB for Hip Reconstruction in Children

Perioperative Analgesia Clinical Trial

Official title:

The Comparison of Pericapsular Nerve Block and Fascia Iliaca Compartment Block in Children With Cerebral Palsy or Spina Bifida for Pain Management in Hip Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210503
• Other study ID #: PENG vs FICB
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Saint Petersburg State University, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the hypothesis that performing a Pericapsular nerve group (PENG) block allows for more effective analgesia in the perioperative period during reconstructive surgery on the hip in children with cerebral palsy and spina bifida compared with Fascia illiaca compartment block (FICB).

Description:

The main question it aims to answer is: Is the PENG block an effective and safe method of pain relief for hip surgery in children? Participants will be randomized into two equal groups. The group who underwent US - guided PENG block, and the group who underwent US - guided FICB . In both groups we used 0.5% ropivacaine. The same postoperative analgesia regimen was applied by intravenous acetaminophen , oral ibuprofen . In case of ineffectiveness of the prescribed drugs, promedol was used intramuscularly. The postoperative consumption of promedol, time to first rescue analgesia, numerical pain score (NRS) (for children from 7 years old), FLACC score, measurements of A.N.I. monitor MDMS and the side effects will be recorded

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• reconstructive surgery on the hip joint

• children with cerebral palsy

• children with spina bifida

• age 3 - 18 years.

Exclusion Criteria:

• contraindications to the use of local anesthetics

• contraindications to performing an invasive procedure

• ASA > 3

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Perioperative Analgesia

Intervention

Procedure:
• Pericapcelar group nerve block
In the supine position, a high-frequency linear sensor is placed in the anterior superior iliac spine and then aligned with the ramus of the pubis by rotating the probe counterclockwise approximately 45 degrees. The iliopsoas muscle and tendon, femoral artery, and pectineus muscle were observed in this view.The iliopsoas muscle and its tendon are visualized, as well as the vascular and nerve bundle: femoral artery, vein, and nerve. The needle is inserted laterally to medially in a planar approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the ramus pubis posteriorly. After negative aspiration, local anesthetic will be gradually injected aspirating every 3 mL.
• Fascia iliaca compartment block
In the supine position, a high-frequency linear sensor is placed in the inguinal fold. Scan starting lateral to the femoral artery and the nerve in the inguinal crease to identify the sartorius muscle, tracing the muscle to its origin to the anterior superior iliac spine. A shadow of the iliac crest bone and iliacus muscle will be visible, with the end point of injection being deep in the fascia iliaca and above the iliacus muscle at the lateral aspect of the iliacus muscle. After negative aspiration, local anesthetic will be gradually injected under the fascial plane, aspirating every 3 mL.

Locations

Country	Name	City	State
Russian Federation	Saint-Petersburg State University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioids consumption	Total dosage of opioids in postoperative period	24 hours
Secondary	Time to rescue analgesia	Time to first accepted of opioid analgesia	24 hours
Secondary	Pain level	Assessing level of pain. Using pain scales. Face, Legs, Activity, Cry, Consolability (FLACC) scale for children from 3 to 7 years old. The scale is scored in a range of 0-10 with 0 representing no pain, and 10 representing maximal pain. Visual Analog Scale (VAS) for children over 7 years old. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	2, 6, 12, 24 hours after completing the block
Secondary	Intraoperative level of analgesia	Analgesia-nociception index (ANI). Using "ANI Monitor".	Intraoperatively