NCT06470542

Brief Summary

Effect of two-level ESPB in Total Knee 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 knee-osteoarthritis

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_4 knee-osteoarthritis

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 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 7, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

November 25, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

June 17, 2024

Last Update Submit

November 19, 2025

Conditions

Knee OsteoarthritisKnee Pain ChronicKnee Arthritis

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption

    Total opioid consumption after surgery - within 48 hours after surgery

    48 hours after surgery

Secondary Outcomes (14)

  • Time to first rescue opioid analgesia

    48 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

  • Numerical Rating Scale [range 0:10]

    48 hours after surgery

  • +9 more secondary outcomes

Study Arms (2)

iPACK + ACB

ACTIVE COMPARATOR

Ultrasound-guided iPACK +ACB

Drug: 2 x 20 ml of Ropivacaine 0.2% Injectable Solution

Two-Level ESPB

ACTIVE COMPARATOR

Bi-level Ultrasound-guided ESPB et the L1 and S1

Drug: 2 x 20ml of Ropivacaine 0.2% Injectable Solution

Interventions

2 x 20 ml of Ropivacaine 0.2% Injectable SolutionDRUG

2 x 20ml 0.2% Ropivacaine - ultrasound-guided iPACK + ACB

Also known as: iPACK + ACB
iPACK + ACB
2 x 20ml of Ropivacaine 0.2% Injectable SolutionDRUG

2 x 20ml 0.2% ropivacaine - ultrasound-guided ESPB at the L1 and S1 level

Also known as: Erector spinae plane block (ESPB)
Two-Level ESPB

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients scheduled for total hip arthroplasty
  • patients aged \>65 and \<100 years
  • patients able to provide informed consent
  • patients able to reliably report symptoms to the research team

You may not qualify if:

  • inability to provide first-party consent due to cognitive impairment or a language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Malgorzata Reysner, M.D. Ph.D.

    Poznań 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 17, 2024

First Posted

June 24, 2024

Study Start

November 7, 2024

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

November 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Detailed data sharing plan to be defined

Time Frame
Data will be shared following the trial completion
Access Criteria
Eligible researchers

Locations

PL(1)