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CompletedNCT06233630Updated Sep 26, 2024

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

A Phase 4 interventional study of Control Test - spinal anesthesia and Ropivacaine 0.2% Injectable Solution ESPB in Knee Osteoarthritis, Knee Pain Chronic and Knee Arthritis, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Knee Pain Chronic
  • Knee Arthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with ASA classification I-III,
  • Aged 20-100 years,
  • scheduled for knee arthroplasty under spinal anaesthesia

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Only spinal anaesthesia - No peripheral nerve block

    Drug: Control Test - spinal anesthesia

  • Active comparator
    Erector Spinae Plane Block

    spinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine

    Drug: Ropivacaine 0.2% Injectable Solution ESPB

  • Active comparator
    Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block

    spinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine + ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine

    Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB

Interventions

  • DrugControl Test - spinal anesthesia

    No peripheral nerve block Only spinal anesthesia

    Also known as: spinal anesthesia

  • DrugRopivacaine 0.2% Injectable Solution ESPB

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

    Also known as: erector spinae plane block

  • DrugRopivacaine 0.2% Injectable Solution iPACK+ACB

    ultrasound guided iPACK block + Adductor Canal Block

    Also known as: iPACK+ACB

06

What researchers measure

Primary outcomes

  1. Opioid consumption

    Total opiate consumption after surgery

    Time frame: 48 hours

Secondary outcomes

  1. first need of opiate

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

    Time frame: 48 hours

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. NLR

    Neutrophil-to-lymphocyte ratio

    Time frame: 24 hours postoperatively

  9. PLR

    Platelet-to-lymphocyte ratio

    Time frame: 24 hours postoperatively

  10. 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

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Poznan University of Medical Sciences
    Poznań, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06233630
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Mar 30, 2024
Primary completion
Aug 16, 2024
Completion
Aug 20, 2024
Last update
Sep 26, 2024

Study contacts

Malgorzata Domagalska, Ph.D.
principal investigator · Poznan University of Medical Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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