ESPB vs iPACK+ACB in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302218
• Other study ID #: 5/2024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: March 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: 608762068
• Email: m.domagalska[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Arthropathy
• Knee Disease
• Knee Osteoarthritis
• Knee Pain Chronic
• Knee Rheumatism
• Rheumatic Diseases

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution
iPACK block + Adductor Canal Block
• Ropivacaine 0.2% Injectable Solution
Erector Spinae Plane Block
• control group
only spinal anesthesia

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Total opiate consumption after surgery	48 hours after surgery
Secondary	Time to first rescue opiate analgesia	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Secondary	Neutrophil-to-lymphocyte ratio	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Secondary	Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	24 hours after surgery
Secondary	Platelet-to-lymphocyte ratio	Platelet-to-lymphocyte ratio	48 hours after surgery
Secondary	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