Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty

September 24, 2024 updated by: Poznan University of Medical Sciences
Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory 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 emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.

Study Type

Interventional

Enrollment (Actual)

90

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, Poland
        • 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 20-100 years,
  • 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
  • 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
Placebo Comparator: Placebo
Only spinal anaesthesia - No peripheral nerve block
Drug: Control Test - spinal anesthesia
No peripheral nerve block Only spinal anesthesia
Other Names:
  • spinal anesthesia
Active Comparator: Erector Spinae Plane Block
spinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine
Drug: Ropivacaine 0.2% Injectable Solution ESPB
ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral
Other Names:
  • erector spinae plane block
Active Comparator: Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block

spinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine

+ ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine
Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB
ultrasound guided iPACK block + Adductor Canal Block
Other Names:
  • iPACK+ACB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 48 hours
Total opiate consumption after surgery
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first need of opiate
Time Frame: 48 hours
Time after surgery when the patient needs opiate for the first time
48 hours
Numerical Rating Scale [range 0:10]
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)
4 hours after surgery
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: 16 hours after surgery
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
16 hours after surgery
Numerical Rating Scale [range 0:10]
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)
20 hours after surgery
NLR
Time Frame: 24 hours postoperatively
Neutrophil-to-lymphocyte ratio
24 hours postoperatively
PLR
Time Frame: 24 hours postoperatively
Platelet-to-lymphocyte ratio
24 hours postoperatively
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

Collaborators and Investigators

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

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Malgorzata Domagalska, Ph.D., Poznań University of Medical Science

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)

March 30, 2024

Primary Completion (Actual)

August 16, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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