ESPB vs iPACK+ACB in Total Knee Arthroplasty

Phase 4

Not yet recruiting

• Conditions: Knee Arthritis; Knee Arthropathy; Knee Osteoarthritis; Knee Pain Chronic; Knee Disease; Knee Rheumatism
• Interventions: Drug: Ropivacaine 0.2% Injectable Solution; Drug: control group

• Registration Number: NCT06302218
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

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 Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Study Start: 2024-04-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPACK + ACB	Ropivacaine 0.2% Injectable Solution	spinal anesthesia + ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)
Erectro Spinae Plane Block	Ropivacaine 0.2% Injectable Solution	spinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine
Control group	control group	Only spinal anesthesia - No peripheral nerve block

Primary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours after surgery	Total opiate consumption after surgery

Secondary Outcome Measures

Name	Time	Method
Neutrophil-to-lymphocyte ratio	48 hours after surgery	Neutrophil-to-lymphocyte ratio
Time to first rescue opiate analgesia	48 hours after procedure	Time after surgery when the patient needs opiate for the first time
Numerical Rating Scale [range 0:10]	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)
Platelet-to-lymphocyte ratio	48 hours after surgery	Platelet-to-lymphocyte ratio
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Postoperative 24 hours period	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland