ClinicalTrials.gg
Active, not recruitingNCT06210503Updated Jul 8, 2025

PENG Block in Comparison With FICB for Hip Reconstruction in Children

An interventional study of Pericapcelar group nerve block and Fascia iliaca compartment block in Perioperative Analgesia and Hip Dislocation, Developmental, sponsored by Saint Petersburg State University, Russia. Active, not recruiting at 1 site in Russia. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Saint Petersburg State University, Russia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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).

Read the 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

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Conditions studied

  • Perioperative Analgesia
  • Hip Dislocation, Developmental

Keywords

  • Anesthesia local
  • nerve block
  • postoperative pain
  • hip dislocation
  • children
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In context

Developmental Dysplasia of the Hip

60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.

This study's planned enrollment of 86 is above the median of 59 across 38 interventional studies indexed under Developmental Dysplasia of the Hip.

Browse Developmental Dysplasia of the Hip studies →

Lead sponsor

Saint Petersburg State University, Russia is the lead sponsor of 34 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to the use of local anesthetics
  • contraindications to performing an invasive procedure
  • ASA > 3
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (estimated)

Study arms

  • Active comparator
    PENG group

    The patient will undergo pericapsular nerve blockade with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning.

    Procedure: Pericapcelar group nerve block

  • Active comparator
    FICB group

    The patient will undergo FICB with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning.

    Procedure: Fascia iliaca compartment block

Interventions

  • ProcedurePericapcelar 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.

  • ProcedureFascia 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.

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What researchers measure

Primary outcomes

  1. Opioids consumption

    Total dosage of opioids in postoperative period

    Time frame: 24 hours

Secondary outcomes

  1. Time to rescue analgesia

    Time to first accepted of opioid analgesia

    Time frame: 24 hours

  2. 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. 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".

    Time frame: 2, 6, 12, 24 hours after completing the block

  3. Intraoperative level of analgesia

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

    Time frame: Intraoperatively

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Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06210503
Lead sponsor
Saint Petersburg State University, Russia
Responsible party
Novikova Veronika (Principal Investigator, Saint Petersburg State University, Russia) — Principal investigator
First posted
Jan 18, 2024
Start date
Dec 4, 2023
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Jul 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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