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Clinical Trials/NCT06302218
NCT06302218
Not yet recruiting
Phase 4

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

Poznan University of Medical Sciences1 site in 1 country60 target enrollmentStarted: April 1, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Poznan University of Medical Sciences
Enrollment
60
Locations
1
Primary Endpoint
Opioid consumption

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

iPACK + ACB

Active Comparator

spinal anesthesia

  • ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)

Intervention: Ropivacaine 0.2% Injectable Solution (Drug)

Erectro Spinae Plane Block

Active Comparator

spinal anesthesia

  • ultrasound guided ESPBk - 20ml 0,2% ropivacaine

Intervention: Ropivacaine 0.2% Injectable Solution (Drug)

Control group

Placebo Comparator

Only spinal anesthesia - No peripheral nerve block

Intervention: control group (Drug)

Outcomes

Primary Outcomes

Opioid consumption

Time Frame: 48 hours after surgery

Total opiate consumption after surgery

Secondary Outcomes

  • Time to first rescue opiate analgesia(48 hours after procedure)
  • Numerical Rating Scale [range 0:10](Time Frame: 48 hours after surgery)
  • Neutrophil-to-lymphocyte ratio(48 hours after surgery)
  • Platelet-to-lymphocyte ratio(48 hours after surgery)
  • Quadriceps muscle strength assessed using medical research council scale [range 0:5](Postoperative 24 hours period)

Investigators

Sponsor
Poznan University of Medical Sciences
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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