PENG Block in Comparison With FICB for Hip Reconstruction in Children
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.
1 other identifier
interventional
86
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2023
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJuly 8, 2025
July 1, 2025
1.9 years
December 21, 2023
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Opioids consumption
Total dosage of opioids in postoperative period
24 hours
Secondary Outcomes (3)
Time to rescue analgesia
24 hours
Pain level
2, 6, 12, 24 hours after completing the block
Intraoperative level of analgesia
Intraoperatively
Study Arms (2)
PENG group
ACTIVE COMPARATORThe patient will undergo pericapsular nerve blockade with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning.
FICB group
ACTIVE COMPARATORThe patient will undergo FICB with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- reconstructive surgery on the hip joint
- children with cerebral palsy/ spina bifida/organic brain injury
- age 3 - 18 years.
You may not qualify if:
- contraindications to the use of local anesthetics
- contraindications to performing an invasive procedure
- ASA \> 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint-Petersburg State University
Saint Petersburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 18, 2024
Study Start
December 4, 2023
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
July 8, 2025
Record last verified: 2025-07