Two-level ESPB in Total Knee Arthroplasty

NCT ID: NCT06470542

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2025-08-05

Brief Summary

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Effect of two-level ESPB in Total Knee Arthroplasty

Detailed Description

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Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Conditions

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Knee Osteoarthritis Knee Pain Chronic Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iPACK + ACB

Ultrasound-guided iPACK +ACB

Group Type ACTIVE_COMPARATOR

2 x 20 ml of Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

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

Two-Level ESPB

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

Group Type ACTIVE_COMPARATOR

2 x 20ml of Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

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

Interventions

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2 x 20 ml of Ropivacaine 0.2% Injectable Solution

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

Intervention Type DRUG

2 x 20ml of Ropivacaine 0.2% Injectable Solution

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

Intervention Type DRUG

Other Intervention Names

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iPACK + ACB Erector spinae plane block (ESPB)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* inability to provide first-party consent due to cognitive impairment or a language barrier
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Reysner, M.D. Ph.D.

Role: STUDY_CHAIR

Poznań University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, Poznań, Poland

Site Status

Countries

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Poland

Other Identifiers

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9/2024

Identifier Type: -

Identifier Source: org_study_id

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