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Completed

NCT Number: NCT06233630

Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Test - spinal anesthesia

Drug

No peripheral nerve block Only spinal anesthesia

Other names: spinal anesthesia

Ropivacaine 0.2% Injectable Solution ESPB

Drug

ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral

Other names: erector spinae plane block

Ropivacaine 0.2% Injectable Solution iPACK+ACB

Drug

ultrasound guided iPACK block + Adductor Canal Block

Other names: iPACK+ACB

Primary outcomes

  1. Opioid consumption

    Time frame: 48 hours

    Total opiate consumption after surgery

Secondary outcomes

  1. first need of opiate

    Time frame: 48 hours

    Time after surgery when the patient needs opiate for the first time

  2. Numerical Rating Scale [range 0:10]

    Time frame: 4 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  3. Numerical Rating Scale [range 0:10]

    Time frame: 8 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  4. Numerical Rating Scale [range 0:10]

    Time frame: 12 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  5. Numerical Rating Scale [range 0:10]

    Time frame: 16 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  6. Numerical Rating Scale [range 0:10]

    Time frame: 20 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  7. Numerical Rating Scale [range 0:10]

    Time frame: 24 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  8. NLR

    Time frame: 24 hours postoperatively

    Neutrophil-to-lymphocyte ratio

  9. PLR

    Time frame: 24 hours postoperatively

    Platelet-to-lymphocyte ratio

  10. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 24 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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