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Completed

NCT Number: NCT04603950

IPICK Blocking for TKA With Moderate Flexion Contracture

Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, China

About this study

From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The diagnosis was knee osteoarthritis
  • The flexion contracture was between 5 and 10 degrees
  • ASA grade I-III

Exclusion criteria

  • Lower extremity neuropathy.
  • Contraindications of nerve anesthesia or regional anesthesia.
  • unable to cooperate, allergic to the drugs used in this study.
  • Non steroidal anti-inflammatory drugs are not tolerated.
  • chronic opioid consumption (daily or almost daily use)

Treatment and study plan

CACB+IPACK

Procedure

continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee

CACB

Procedure

continue adductor canal block

Primary outcomes

  1. evaluation of pain

    Time frame: 6 hours after surgery

    Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

  2. evaluation of pain

    Time frame: postoperative day 1

    Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

  3. evaluation of pain

    Time frame: postoperative day 2

    Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

  4. evaluation of pain

    Time frame: postoperative day 3

    Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

  5. extension angle

    Time frame: before surgery

    degree of the extension of knee

  6. extension angle

    Time frame: 0 hour after surgery

    degree of the extension of knee

  7. extension angle

    Time frame: 6 hour after surgery

    degree of the extension of knee

  8. extension angle

    Time frame: postoperative day 1

    degree of the extension of knee

  9. extension angle

    Time frame: postoperative day 2

    degree of the extension of knee

  10. extension angle

    Time frame: postoperative day 3

    degree of the extension of knee

Secondary outcomes

  1. range of motion

    Time frame: 6 hour after surgery

    degree of range of motion from extension to flexion of knee

  2. range of motion

    Time frame: postoperative day 1

    degree of range of motion from extension to flexion of knee

  3. range of motion

    Time frame: postoperative day 2

    degree of range of motion from extension to flexion of knee

  4. range of motion

    Time frame: postoperative day 3

    degree of range of motion from extension to flexion of knee

  5. opioid consumption

    Time frame: through hospitalization, an average of 7 days

    total opioid consumption measured by milliliter.

  6. nerve block related symptoms

    Time frame: through hospitalization, an average of 7 days

    the incidence of numbness of the nerve related skin

  7. postoperative acute pain

    Time frame: through hospitalization, an average of 7 days

    number of cases whose Visual Analog Score for pain was more than 5

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2020
Registry last updated
Jul 26, 2022

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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