NCT06210503

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

December 21, 2023

Last Update Submit

July 2, 2025

Conditions

Keywords

Anesthesia localnerve blockpostoperative painhip dislocationchildren

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 COMPARATOR

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

FICB group

ACTIVE COMPARATOR

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

Procedure: Fascia iliaca compartment block

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.

PENG group

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.

FICB group

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Developmental Dysplasia of the HipPain, PostoperativeHip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsWounds and InjuriesHip Injuries

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

Locations