ESPB vs iPACK+ACB in Total Knee Arthroplasty

March 4, 2024 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

Not yet recruiting

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 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

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
Intervention / Treatment
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

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

Outcome Measure
Measure Description
Time Frame
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
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

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: Łukasz Łapaj, 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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