NCT03562559

Brief Summary

To control pain after total knee replacement surgery a catheter (tubing) is sometimes inserted into an anatomic space containing nerves that provide sensation to parts of the knee. This space is called the adductor canal. The catheters often stop working before we remove them for unclear reasons. The investigators think this is because the catheters become dislodged from where it was meant to be. This could be due to repeated movements of the catheter tip brought on by patients contracting their leg muscles when they ambulate or perform physio. The investigators want to confirm this by measuring the distance from a fixed spot on the patient's thigh to the adductor canal using an ultrasound machine. The leg will be measured in various positions to simulate muscle movements. A significant change in the distance could possibly contribute to catheter dislodgement and result in catheter failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

May 29, 2018

Results QC Date

January 5, 2019

Last Update Submit

September 24, 2019

Conditions

Keywords

Total Knee ArthroplastyAdductor Canal Block

Outcome Measures

Primary Outcomes (1)

  • Skin to Adductor Canal Distance Disparity

    The largest distance disparity as measured from the 5 different leg positions

    Measurements will be made on the day of surgery, no other assessment or follow up needed

Study Arms (1)

TKA Patients

Other: Measurements Using Ultrasound

Interventions

Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.

TKA Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We are recruiting patients undergoing total knee replacement. Per hospital protocol, patients will receive a spinal anesthetic and adductor canal block as part of their anesthetic regimen. After surgery, previously consented patients will have their skin to adductor canal distance measured by ultrasound in 5 different positions.

You may qualify if:

  • Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
  • Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia

You may not qualify if:

  • Patients with an allergy to ultrasound transducer gel or measuring tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Publications (1)

  • Tholin M, Wilson J, Lee S, Tang R, Sawka A, Vaghadia H. Impact of leg movement on skin-adductor canal distance: a potential cause for catheter tip displacement? Can J Anaesth. 2020 Aug;67(8):936-941. doi: 10.1007/s12630-020-01693-6. Epub 2020 May 8.

Results Point of Contact

Title
Marcus Tholin
Organization
Vancouver General Hospital

Study Officials

  • Jason Wilson, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 19, 2018

Study Start

April 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 27, 2019

Results First Posted

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations