IPICK Blocking for TKA With Moderate Flexion Contracture

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04603950
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Flexion Contracture of Knees; Anesthesia, Local	Procedure: CACB+IPACK; Procedure: CACB	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group The first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee	Procedure: CACB+IPACK; continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee
Sham Comparator: control group The second 20 patients received Continue Adductor Canal Block alone	Procedure: CACB; continue adductor canal block

Outcome Measures

Primary Outcome Measures

1. evaluation of pain [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 [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 [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 [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 [before surgery]

   degree of the extension of knee

6. extension angle [0 hour after surgery]

   degree of the extension of knee

7. extension angle [6 hour after surgery]

   degree of the extension of knee

8. extension angle [postoperative day 1]

   degree of the extension of knee

9. extension angle [postoperative day 2]

   degree of the extension of knee

10. extension angle [postoperative day 3]

    degree of the extension of knee

Secondary Outcome Measures

1. range of motion [6 hour after surgery]

   degree of range of motion from extension to flexion of knee

2. range of motion [postoperative day 1]

   degree of range of motion from extension to flexion of knee

3. range of motion [postoperative day 2]

   degree of range of motion from extension to flexion of knee

4. range of motion [postoperative day 3]

   degree of range of motion from extension to flexion of knee

5. opioid consumption [through hospitalization, an average of 7 days]

   total opioid consumption measured by milliliter.

6. nerve block related symptoms [through hospitalization, an average of 7 days]

   the incidence of numbness of the nerve related skin

7. postoperative acute pain [through hospitalization, an average of 7 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Jilin University	Changchun		China

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT04603950
• Other Study ID Numbers: QiXin2
• First Posted: Oct 27, 2020
• Last Update Posted: Jul 26, 2022
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Hospital of Jilin University: IPACK; knee osteoarthritis; Flexion Contracture of Knees
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Contracture

Study Results

No Results Posted as of Jul 26, 2022