PENG Block in Comparison With FICB for Hip Reconstruction in Children

Not Applicable

Active, not recruiting

• Conditions: Hip Dislocation, Developmental; Perioperative Analgesia

• Registration Number: NCT06210503
• Lead Sponsor: Saint Petersburg State University, Russia

Brief 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).

Detailed 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

Study Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• reconstructive surgery on the hip joint
• children with cerebral palsy/ spina bifida/organic brain injury
• age 3 - 18 years.

Exclusion Criteria

• contraindications to the use of local anesthetics
• contraindications to performing an invasive procedure
• ASA > 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioids consumption	24 hours	Total dosage of opioids in postoperative period

Secondary Outcome Measures

Name	Time	Method
Time to rescue analgesia	24 hours	Time to first accepted of opioid analgesia
Pain level	2, 6, 12, 24 hours after completing the block	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. The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.; Analgesia-nociception index (ANI). Using "ANI Monitor".
Intraoperative level of analgesia	Intraoperatively	Analgesia-nociception index (ANI). Using "ANI Monitor".

Trial Locations

Locations (1)

Saint-Petersburg State University; 🇷🇺 Saint Petersburg, Russian Federation