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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05961085
Other study ID # 5845
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 10, 2023
Est. completion date December 2025

Study information

Verified date July 2023
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to determine the incidence of dislodgement for adductor canal catheters after total knee arthroplasty on post-operative day 1. We will also attempt to identify factors associated with secondary catheter failure.


Description:

Total knee arthroplasty (TKA) is a common procedure for indications including osteoarthritis and malignancy involving the knee, with over 55,285 knee replacements performed between 2020-2021 in Canada. Ultrasound guided continuous adductor canal block (cACB) is the standard of care for postoperative analgesia for this procedure. The catheter is not always as effective at providing analgesia as would be expected - which could be due to displacement of the catheter. This displacement is most likely to occur peri-operatively or during physiotherapy post-operatively and as such, post-operative assessments can provide useful insight into causes of secondary failure. This prospective observational study aims to estimate the cACB dislodgment on POD 1 rate at a high volume, tertiary care referral centre, and identify factors associated with dislodgement and clinical sequelae. As this is an observational/QI study of the current standard of care at Sunnybrook Health Sciences Centre, anesthesiologists are free to use the cross sectional versus parallel insertion of the cACB per their discretion.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Patients scheduled for Total Knee Arthroplasty - Older than 50 years Exclusion Criteria: - Body Mass Index greater than 40 - Chronic opioid consumption (greater than 30mg oral morphine equivalent daily) - Contraindication to Adductor Canal Catheter

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Adductor Canal Catheter
Ultrasound guided Adductor Canal Catheter for total knee arthroplasty analgesia

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Adductor catheter occlusion Any recording of local anesthetic infusion pump recording an occlusion Postoperative day 1 (08:00AM)
Other Patient satisfaction with analgesia on postoperative day 1 Patient satisfaction measured by 0-10 Likert Scale Postoperative day 1 (08:00AM)
Primary Adductor Canal Catheter tip in correct position on postoperative day 1 Ultrasound confirmation of injectate spread adjacent to the femoral artery on postoperative day 1 (08h00) Postoperative day 1 (08:00AM)
Secondary Adductor Canal Catheter tip in correct position after insertion Ultrasound confirmation of injectate spread adjacent to the femoral artery before surgery Preoperative
Secondary Sensory block Loss of sensation in the saphenous nerve distribution on postoperative day 1 (08h00) Postoperative day 1 (08:00AM)
Secondary Postoperative opioid consumption (08h00) Cumulative opioid consumption after total knee arthroplasty to postoperative day 1 (08h00) Postoperative day 1 (08:00AM)
Secondary Numeric Rating Scale for Pain (NRS) at rest on postoperative day 1 (08h00) Maximum pain score on 0-10 Likert Scale Postoperative day 1 (08:00AM)
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