NCT06087588

Brief Summary

PENG neurolysis in advanced osteoarthritis of the hip joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

January 21, 2025

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

July 5, 2023

Last Update Submit

January 17, 2025

Conditions

OsteoarthritisOsteoarthritis, Hip

Outcome Measures

Primary Outcomes (4)

  • NRS score

    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    7 days after procedure

  • NRS score

    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    30 days after procedure

  • NRS score

    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    3 months after procedure

  • NRS score

    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    6 months after procedure

Secondary Outcomes (12)

  • Health Questionnaire (EQ-5D-5L)

    7 days after procedure

  • Health Questionnaire (EQ-5D-5L)

    30 days after procedure

  • Health Questionnaire (EQ-5D-5L)

    3 months after procedure

  • Health Questionnaire (EQ-5D-5L)

    6 months after procedure

  • neurological deficits

    7 days after procedure

  • +7 more secondary outcomes

Study Arms (2)

sham PENG block

ACTIVE COMPARATOR

PENG block - 20ml 0,9% normal saline

Drug: 0.9%sodium chloride

PENG neurolysis

ACTIVE COMPARATOR

PENG neurolysis with 5ml 95% ethanol

Drug: 95% ethanol

Interventions

0.9%sodium chlorideDRUG

PENG sham block with 20ml 0,9% normal saline

Also known as: Sham block
sham PENG block
95% ethanolDRUG

PENG neurolysis with 2.5ml of 95% ethanol

Also known as: neurolysis
PENG neurolysis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
  • patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgetics
  • Age of patients: from 18 to 110 years of age.
  • Caucasian patients can give informed, complete, written consent.

You may not qualify if:

  • suspected or diagnosed opioid dependence syndrome
  • active cancer
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

Related Publications (1)

  • Reysner M, Reysner T, Kowalski G, Mularski A, Daroszewski P, Wieczorowska-Tobis K. Chemical ablation of pericapsular nerve group with 95% ethanol for pain relief and quality of life in patients with hip osteoarthritis: a prospective, double-blinded, randomised, controlled trial. Br J Anaesth. 2025 Aug;135(2):382-389. doi: 10.1016/j.bja.2025.04.045. Epub 2025 Jun 6.

    PMID: 40480912DERIVED

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Hip

Interventions

Sodium ChlorideEthanolNerve Block

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAlcoholsOrganic ChemicalsAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Katarzyna Wieczorowska-Tobis, Prof.dr hab

    Poznań University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

October 18, 2023

Study Start

October 17, 2023

Primary Completion

January 10, 2025

Study Completion

January 14, 2025

Last Updated

January 21, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)