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

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ClinicalTrials.gov Identifier: NCT02228759
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sugantha Ganapathy, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Adductor canal block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




Primary Outcome Measures :
  1. percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. first 24 hour pain scores [ Time Frame: 24 hours ]
  2. first 96 hour pain scores [ Time Frame: 96 hours ]
  3. Rescue analgesic frequency [ Time Frame: 24 hours ]
  4. total analgesic usage in the first 24 and 96 postoperative hours [ Time Frame: 96 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228759


Locations
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Canada, Ontario
University hospital, London Health Sciences centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute

Publications:
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Responsible Party: Sugantha Ganapathy, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02228759     History of Changes
Other Study ID Numbers: 105097
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Sugantha Ganapathy, Lawson Health Research Institute:
Ambulatory home regional
adductor canal block
Postoperative pain
total knee arthroplasty
Home regional
Fast track arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases