IPICK Blocking for TKA With Moderate Flexion Contracture

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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Anesthesia, Local; Flexion Contracture of Knees
• Intervention / Treatment: Procedure: CACB+IPACK; Procedure: CACB

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
extension angle	degree of the extension of knee	before surgery
extension angle	degree of the extension of knee	0 hour after surgery
extension angle	degree of the extension of knee	6 hour after surgery
extension angle	degree of the extension of knee	postoperative day 1
extension angle	degree of the extension of knee	postoperative day 2
extension angle	degree of the extension of knee	postoperative day 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: knee osteoarthritis; IPACK; Flexion Contracture of Knees
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Osteoarthritis; Osteoarthritis, Knee; Contracture
• Other Study ID Numbers: QiXin2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No