ESPB vs iPACK+ACB in Total Knee Arthroplasty

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: Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy; Knee Pain Chronic; Knee Disease; Knee Rheumatism
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution; Drug: control group

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

• Study Contact: Name: Malgorzata Domagalska, Ph.D.; Phone Number: 608762068; Email: m.domagalska@ump.edu.pl
• Study Contact Backup: Name: Małgorzata Domagalska, Ph.D.; Phone Number: 61 873 83 03; Email: m.domagalska@ump.edu.pl

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • 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 20-90 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

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
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	Total opiate consumption after surgery	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	24 hours after surgery
Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	48 hours after surgery
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	Postoperative 24 hours period
Time to first rescue opiate analgesia	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
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)	Time Frame: 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)	Time Frame: 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)	Time Frame: 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)	Time Frame: 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)	Time Frame: 20 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)	Time Frame: 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)	Time Frame: 36 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)	Time Frame: 48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Łukasz Łapaj, Ph.D., Poznan University of Medical Sciences

Study record dates

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: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• 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