ESPB vs iPACK+ACB in Total Knee Arthroplasty

November 4, 2026 updated by: Poznan University of Medical Sciences

Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement

Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 surgery's induced stress response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.

This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.

Exclusion Criteria:

  • patients who have a history of bleeding diathesis,
  • take anticoagulant therapy,
  • have a History of chronic pain before surgery,
  • have Multiple trauma, cannot assess their pain (dementia),
  • have been operated on under general anaesthesia,
  • have an infection in the area and do not accept the procedure

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: iPACK + ACB

spinal anesthesia

+ ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)
Drug: Ropivacaine 0.2% Injectable Solution

iPACK block + Adductor Canal Block

Other Names:
  • iPACK + ACB
Drug: Ropivacaine 0.2% Injectable Solution

Erector Spinae Plane Block

Other Names:
  • ESPB
Active Comparator: Erectro Spinae Plane Block

spinal anesthesia

+ ultrasound guided ESPBk - 20ml 0,2% ropivacaine
Drug: Ropivacaine 0.2% Injectable Solution

iPACK block + Adductor Canal Block

Other Names:
  • iPACK + ACB
Drug: Ropivacaine 0.2% Injectable Solution

Erector Spinae Plane Block

Other Names:
  • ESPB
Placebo Comparator: Control group

Only spinal anesthesia - No peripheral nerve block
Drug: control group

only spinal anesthesia

Other Names:
  • only spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 48 hours after surgery

Total opiate consumption after surgery
48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first rescue opiate analgesia
Time Frame: 48 hours after procedure

Time after surgery when the patient needs opiate for the first time
48 hours after procedure
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 4 hours after surgery

Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 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)
Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 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)
Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 16 hours after surgery

Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 20 hours after surgery

Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 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)
Time Frame: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 36 hours after surgery

Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame: 36 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 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)
Time Frame: 48 hours after surgery
Neutrophil-to-lymphocyte ratio
Time Frame: 24 hours after surgery

Neutrophil-to-lymphocyte ratio
24 hours after surgery
Neutrophil-to-lymphocyte ratio
Time Frame: 48 hours after surgery

Neutrophil-to-lymphocyte ratio
48 hours after surgery
Platelet-to-lymphocyte ratio
Time Frame: 24 hours after surgery

Platelet-to-lymphocyte ratio
24 hours after surgery
Platelet-to-lymphocyte ratio
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: Postoperative 24 hours period

Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Postoperative 24 hours period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Łukasz Łapaj, Ph.D., Poznań 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Please provide the plan description

IPD Sharing Time Frame

6 month after study completion

IPD Sharing Access Criteria

from the corresponding author on the resonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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