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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04603950
Other study ID # QiXin2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date March 31, 2021

Study information

Verified date October 2020
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date March 31, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: 1. The diagnosis was knee osteoarthritis 2. The flexion contracture was between 5 and 10 degrees 3. ASA grade I-III Exclusion Criteria: 1. Lower extremity neuropathy. 2. Contraindications of nerve anesthesia or regional anesthesia. 3. unable to cooperate, allergic to the drugs used in this study. 4. Non steroidal anti-inflammatory drugs are not tolerated. 5. chronic opioid consumption (daily or almost daily use)

Study Design


Intervention

Procedure:
CACB+IPACK
continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee
CACB
continue adductor canal block

Locations

Country Name City State
China The First Hospital of Jilin University Changchun

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluation of pain 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. 6 hours after surgery
Primary evaluation of pain 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. postoperative day 1
Primary evaluation of pain 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. postoperative day 2
Primary evaluation of pain 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. postoperative day 3
Primary extension angle degree of the extension of knee before surgery
Primary extension angle degree of the extension of knee 0 hour after surgery
Primary extension angle degree of the extension of knee 6 hour after surgery
Primary extension angle degree of the extension of knee postoperative day 1
Primary extension angle degree of the extension of knee postoperative day 2
Primary extension angle degree of the extension of knee postoperative day 3
Secondary range of motion degree of range of motion from extension to flexion of knee 6 hour after surgery
Secondary range of motion degree of range of motion from extension to flexion of knee postoperative day 1
Secondary range of motion degree of range of motion from extension to flexion of knee postoperative day 2
Secondary range of motion degree of range of motion from extension to flexion of knee postoperative day 3
Secondary opioid consumption total opioid consumption measured by milliliter. through hospitalization, an average of 7 days
Secondary nerve block related symptoms the incidence of numbness of the nerve related skin through hospitalization, an average of 7 days
Secondary postoperative acute pain number of cases whose Visual Analog Score for pain was more than 5 through hospitalization, an average of 7 days
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