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Active, Not Recruiting

NCT Number: NCT06210503

PENG Block in Comparison With FICB for Hip Reconstruction in Children

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericapcelar group nerve block

Procedure

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

Procedure

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.

Primary outcomes

  1. Opioids consumption

    Time frame: 24 hours

    Total dosage of opioids in postoperative period

Secondary outcomes

  1. Time to rescue analgesia

    Time frame: 24 hours

    Time to first accepted of opioid analgesia

  2. Pain level

    Time frame: 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".

  3. Intraoperative level of analgesia

    Time frame: Intraoperatively

    Analgesia-nociception index (ANI). Using "ANI Monitor".

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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