Two-level ESPB in Total Knee Arthroplasty

November 19, 2025 updated by: Poznan University of Medical Sciences

Two-level Erector Spinae vs iPack With ACB Plane Block in Total Knee Arthroplasty

Effect of two-level ESPB in Total Knee Arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Poznań
      • Poznan, Poznań, Poland, 61-701
        • Poznan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iPACK + ACB
Ultrasound-guided iPACK +ACB
Drug: 2 x 20 ml of Ropivacaine 0.2% Injectable Solution
2 x 20ml 0.2% Ropivacaine - ultrasound-guided iPACK + ACB
Other Names:
  • iPACK + ACB
Active Comparator: Two-Level ESPB
Bi-level Ultrasound-guided ESPB et the L1 and S1
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
Other Names:
  • Erector spinae plane block (ESPB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opioid Consumption
Time Frame: 48 hours after surgery
Total opioid consumption after surgery - within 48 hours after surgery
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale [range 0:10]
Time Frame: 8 hours after surgery
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
8 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 12 hours after surgery
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
12 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 24 hours after surgery
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
24 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 48 hours after surgery
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
48 hours after surgery
NLR
Time Frame: 48 hours after surgery
neutrophil-to-lymphocyte ratio
48 hours after surgery
PLR
Time Frame: 48 hours after surgery
platelet-to-lymphocyte ratio
48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time Frame: 24 hours after surgery
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
24 hours after surgery
Time to first rescue opioid analgesia
Time Frame: 48 hours after surgery
Time after surgery when the patient needs opiate for the first time
48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time Frame: 4 hours after surgery
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time Frame: 8 hours after surgery
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time Frame: 12 hours after surgery
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time Frame: 48 hours after surgery
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
48 hours after surgery
PLR
Time Frame: 24 hours after surgery
platelet-to-lymphocyte ratio
24 hours after surgery
NLR
Time Frame: 24 hours after surgery
neutrophil-to-lymphocyte ratio
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Study Chair: Malgorzata Reysner, M.D. Ph.D., Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Detailed data sharing plan to be defined

IPD Sharing Time Frame

Data will be shared following the trial completion

IPD Sharing Access Criteria

Eligible researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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