Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study

March 7, 2017 updated by: Sugantha Ganapathy, Lawson Health Research Institute
Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. The study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. We will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University hospital, London Health Sciences centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and females of 40-70years of age
  2. Scheduled to undergo unilateral primary total knee arthroplasty
  3. ASA Class I, II

Exclusion Criteria:

  1. ASA 3, 4
  2. Revision surgery
  3. Narcotic dependent (opioid intake morphine equivalent > 10 mg/ day for more than 3 months)
  4. Other sources of chronic pain like fibromyalgia
  5. Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)
  6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease
  7. Recent MI/ Stroke/ CHF (in the past 3 months)
  8. BMI> 35
  9. Obstructive sleep apnea (AHI > 15)
  10. Patients with coexisting hematological disorder or with deranged coagulation parameters.
  11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  12. Psychiatric illnesses
  13. Uncontrolled diabetes mellitus
  14. Lack of informed consent.
  15. Allergy to any of the drugs used in the study
  16. Preoperative neurological deficits
  17. Use of walking aids preoperatively
  18. Living alone (Lack of Chaperone/home help)
  19. Language barrier
  20. Contralateral leg weakness
  21. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor canal block
The study is an open label pilot study to determine the feasibility of same day discharge following total knee arthroplasty with the use of a fast track regimen employing motor sparing knee blocks. The study will be performed on 25 American Society of Anesthesiologists class (ASA) 1-2 patients satisfying the inclusion criteria and undergoing unilateral primary total knee arthroplasty. First and second patients of the day undergoing surgery between Monday to Thursday in a week will be accessed for the study.
Procedure: Adductor canal block
All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
first 24 hour pain scores
Time Frame: 24 hours
24 hours
first 96 hour pain scores
Time Frame: 96 hours
96 hours
Rescue analgesic frequency
Time Frame: 24 hours
24 hours
total analgesic usage in the first 24 and 96 postoperative hours
Time Frame: 96 hours
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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