NCT07023094

Brief Summary

This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
2mo left

Started Jun 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
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 Progress86%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

June 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

June 8, 2025

Last Update Submit

July 8, 2025

Conditions

Hip DiseaseHip DysplasiaHip Arthropathy

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption

    Total opiate consumption after surgery

    48 hours after surgery

Secondary Outcomes (12)

  • Time to first rescue opioid analgesia

    48 hours after surgery

  • Numerical Rating Scale [range 0:10]

    4 hours after surgery

  • Numerical Rating Scale [range 0:10]

    8 hours after surgery

  • Numerical Rating Scale [range 0:10]

    12 hours after surgery

  • Numerical Rating Scale [range 0:10]

    24 hours after surgery

  • +7 more secondary outcomes

Study Arms (2)

PENG + LFCB

ACTIVE COMPARATOR

U-S guided PENG block - 0.4ml/kg 0.2% ropivacaine \+ U-S guided LFCB - 0.1ml/kg 0.2% ropivacaine

Drug: Ropivacaine 0.2% for PENG BlockDrug: Ropivacaine 0.2% for LFCB

L-ESPB + S-ESPB

ACTIVE COMPARATOR

U-S guided L-ESPB - 0.25ml/kg 0.2% ropivacaine \+ U-S guided S-ESPB - 0.25ml/kg 0.2% ropivacaine

Drug: Ropivacaine 0.2% for L-ESPBDrug: Ropivacaine 0.2% for S-ESPB

Interventions

Ropivacaine 0.2% for PENG BlockDRUG

U-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine

PENG + LFCB
Ropivacaine 0.2% for LFCBDRUG

LFCB (0.1 mL/kg) with 0.2% ropivacaine

PENG + LFCB
Ropivacaine 0.2% for L-ESPBDRUG

Lumbar ESPB (0.25ml/kg) with 0.2% ropivacaine

L-ESPB + S-ESPB
Ropivacaine 0.2% for S-ESPBDRUG

Sacral ESPB (0.25ml/kg) with 0.2% ropivacaine

L-ESPB + S-ESPB

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients aged between 2 and 16 years.
  • Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries
  • ASA (American Society of Anesthesiologists) physical status classification: I-III.
  • Written informed consent obtained from the patient's legal guardian(s).

You may not qualify if:

  • Known allergy or hypersensitivity to any of the study medications
  • Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.
  • Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.
  • Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.
  • Cognitive impairment or behavioral disorders significantly affecting pain assessment accuracy or cooperation.
  • History of chronic opioid use or known substance abuse.
  • Severe systemic disease or condition compromising patient safety or interfering with study protocol adherence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Malgorzata Reysner, M.D. Ph.D.

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malgorzata Reysner

CONTACT

+48 61 873 83 03mreysner@ump.edu.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 15, 2025

Study Start

June 16, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations

PL(1)