Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Total Knee Arthroplasty

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: Not yet recruiting
• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic
• Intervention / Treatment: Drug: Control Test - spinal anesthesia; Drug: Ropivacaine 0.2% Injectable Solution ESPB; Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB

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 (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Malgorzata Domagalska, Ph.D.; Phone Number: 608762068; Email: m.domagalska@icloud.com
• Study Contact Backup: Name: Katarzyna Wieczorowska-Tobis, Ph.D.; Phone Number: +48 61 873 83 03; Email: kwt@tobis.pl

Study Locations

• Poland
  • Poznań, Poland
    • Poznan University of Medical Sciences

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Total opiate consumption after surgery	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Numerical Rating Scale [range 0:10]	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]	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]	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]	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]	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]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	20 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	24 hours postoperatively
PLR	Platelet-to-lymphocyte ratio	24 hours postoperatively
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	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

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Malgorzata Domagalska, Ph.D., Poznan University of Medical Science

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): May 30, 2025

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): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Pharmaceutical Solutions; Ropivacaine
• 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