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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233630
• Other study ID #: 4/2024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 30, 2024
• Est. completion date: May 30, 2025

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Control Test - spinal anesthesia
No peripheral nerve block Only spinal anesthesia
• Ropivacaine 0.2% Injectable Solution ESPB
ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral
• Ropivacaine 0.2% Injectable Solution iPACK+ACB
ultrasound guided iPACK block + Adductor Canal Block

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	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
Secondary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
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)	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)	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)	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)	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)	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)	24 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	24 hours postoperatively
Secondary	PLR	Platelet-to-lymphocyte ratio	24 hours postoperatively
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	24 hours after surgery