Clinical trial NCT06302218: ESPB vs iPACK+ACB in Total Knee Arthroplasty
Official title: Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Knee Arthritis
Knee Arthropathy
Knee Osteoarthritis
Knee Pain Chronic
Knee Disease
Knee Rheumatism
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Time to first rescue opiate analgesia
timeFrame: 48 hours after procedure
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 36 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 48 hours after surgery
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 48 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 48 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: Postoperative 24 hours period
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Sciences
name: Łukasz Łapaj, Ph.D.
role: STUDY_CHAIR
References: