NCT07023107

Brief Summary

Effect of PENG block on NLR and PLR following hip arthroplasty

Trial Health

87
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
Completed

Started Jun 2025

Shorter than P25 for phase_4

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

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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

December 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 8, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neutrophil-to-lymphocyte ratio

    Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.

    12 hours after surgery

Secondary Outcomes (11)

  • PLR

    12 hours after surgery

  • PLR

    24 hours after surgery

  • PLR

    48 hours after surgery

  • NLR

    24 hours after surgery

  • NLR

    48 hours after surgery

  • +6 more secondary outcomes

Study Arms (2)

Sham blocks

PLACEBO COMPARATOR

PENG block with 20ml of 0.9% sodium chloride

Drug: 0.9% Sodium Chloride Injection

PENG block

ACTIVE COMPARATOR

PENG block with 20ml 0f 0.2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution

Interventions

After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride

Sham blocks

After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine

PENG block

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA classification I-III
  • Aged 60-100 years
  • Who will be scheduled for hip arthroplasty under spinal anesthesia

You may not qualify if:

  • Patients who have a history of bleeding diathesis
  • Take anticoagulant therapy
  • History of chronic pain before surgery
  • Multiple trauma
  • patients unable to assess their pain (dementia)
  • patients operated under general anesthesia
  • patients having an infection in the region of the procedure
  • the patient who does not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Sodium ChlorideRopivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Malgorzata Reysner, M.D. Ph.D.

    Poznan University of Medical Sciences

    STUDY CHAIR

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

December 9, 2025

Study Completion

December 9, 2025

Last Updated

December 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations