Skip to main content
OpenTrials
Completed

NCT Number: NCT03038425

Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?

This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthroplasty, Replacement, Knee Ambulatory Surgical Procedures Anesthesia, Regional Nerve Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient characteristics suitable for subvastus approach as determined by single surgeon
  • patients willing to undergo ambulatory surgery
  • ability to read and verbally communicate via either English or French

Exclusion criteria

  • age > 80
  • driving distance greater than 1 hour from hospital
  • no willing caregiver at home on night of surgery
  • renal failure requiring dialysis
  • Insulin-dependent diabetes mellitus
  • BMI > 45
  • allergy to study medications
  • pre-existing neurologic deficit involving the ipsilateral limb
  • chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks).
  • inability to use or manage cACB catheter and pump independently at home
  • inability or refusal to cryocompressive therapy device.

Treatment and study plan

normal saline

Drug

This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect

Ropivacaine

Drug

This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA

Primary outcomes

  1. Quality of Recovery Scale 15 (QoR-15)

    Time frame: at 4pm on post-operative day (POD) 1

    QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.

Secondary outcomes

  1. Quality of Recovery Scale 15 (QoR-15)

    Time frame: POD 2-4 + 7

  2. Pain score at rest

    Time frame: POD 1-4 + 7

    Patients will rate their pain on a scale of 0-10

  3. Pain score with activity

    Time frame: POD 1-4 + 7

    Patients will rate their pain on a scale of 0-10

  4. Tapentadol consumption

    Time frame: POD 1-4 + 7

    Daily tapentadol use in milligrams

  5. Patient satisfaction

    Time frame: POD 1-4 + 7

    Patients will be asked "are you satisfied with your pain control"

  6. Vital signs - blood pressure, heart rate, oxygen saturation

    Time frame: twice daily POD 1-4

    These measurements will be obtained via post-operative home monitoring system

  7. Patient-rated catheter effectiveness

    Time frame: POD 1-4

    Patients will be asked "do you think the nerve block catheter is helpful? Rate on a 5-point scale"

  8. Catheter specific complications

    Time frame: POD 1-4

    Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications

  9. Peri-operative complications

    Time frame: POD 30

    Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported

  10. Timed-up-and-go (TUG) test

    Time frame: POD 14

    TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Ottawa Hospital Academic Medical Association

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2017
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.