Two-level ESPB in Total Knee Arthroplasty

Phase 4

Recruiting

• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic
• Interventions: Drug: 2 x 20 ml of Ropivacaine 0.2% Injectable Solution; Drug: 2 x 20ml of Ropivacaine 0.2% Injectable Solution

• Registration Number: NCT06470542
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of two-level ESPB in Total 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 inflammatory response, opioid consumption, and opioid-related side effects.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Study Start: 2024-11-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

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

Inclusion Criteria

• patients scheduled for total hip arthroplasty
• patients aged >65 and <100 years
• patients able to provide informed consent
• patients able to reliably report symptoms to the research team

Exclusion Criteria

• inability to provide first-party consent due to cognitive impairment or a language barrier

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPACK + ACB	2 x 20 ml of Ropivacaine 0.2% Injectable Solution	Ultrasound-guided iPACK +ACB
Two-Level ESPB	2 x 20ml of Ropivacaine 0.2% Injectable Solution	Bi-level Ultrasound-guided ESPB et the L1 and S1

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption	48 hours after surgery	Total opioid consumption after surgery - within 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale [range 0:10]	48 hours after surgery	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
NLR	48 hours after surgery	neutrophil-to-lymphocyte ratio
PLR	48 hours after surgery	platelet-to-lymphocyte ratio
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	48 hours after surgery	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Time to first rescue opioid analgesia	48 hours after surgery	Time after surgery when the patient needs opiate for the first time

Trial Locations

Locations (1)

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