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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adductor canal block
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Ambulatory home regional, adductor canal block, Postoperative pain, total knee arthroplasty, Home regional, Fast track arthroplasty

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital, London Health Sciences centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adductor canal block

Arm Description

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.

Outcomes

Primary Outcome Measures

percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria

Secondary Outcome Measures

first 24 hour pain scores
first 96 hour pain scores
Rescue analgesic frequency
total analgesic usage in the first 24 and 96 postoperative hours

Full Information

First Posted
August 18, 2014
Last Updated
March 7, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02228759
Brief Title
Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Ambulatory home regional, adductor canal block, Postoperative pain, total knee arthroplasty, Home regional, Fast track arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor canal block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Adductor canal block
Intervention Description
All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
first 24 hour pain scores
Time Frame
24 hours
Title
first 96 hour pain scores
Time Frame
96 hours
Title
Rescue analgesic frequency
Time Frame
24 hours
Title
total analgesic usage in the first 24 and 96 postoperative hours
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and females of 40-70years of age Scheduled to undergo unilateral primary total knee arthroplasty ASA Class I, II Exclusion Criteria: ASA 3, 4 Revision surgery Narcotic dependent (opioid intake morphine equivalent > 10 mg/ day for more than 3 months) Other sources of chronic pain like fibromyalgia Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve) Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease Recent MI/ Stroke/ CHF (in the past 3 months) BMI> 35 Obstructive sleep apnea (AHI > 15) Patients with coexisting hematological disorder or with deranged coagulation parameters. Patients with pre-existing major organ dysfunction such as hepatic and renal failure. Psychiatric illnesses Uncontrolled diabetes mellitus Lack of informed consent. Allergy to any of the drugs used in the study Preoperative neurological deficits Use of walking aids preoperatively Living alone (Lack of Chaperone/home help) Language barrier Contralateral leg weakness Pregnancy
Facility Information:
Facility Name
University hospital, London Health Sciences centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18362603
Citation
Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.
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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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