Knee OsteoarthritisNCT02228759
Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
A study testing Adductor canal block in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Adductor canal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females of 40-70years of age
- Scheduled to undergo unilateral primary total knee arthroplasty
- ASA Class I, II
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University hospital, London Health Sciences centre
London, Ontario, N6A 5A5
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Adductor canal block
- Keywords
- Ambulatory home regional, adductor canal block, Postoperative pain, total knee arthroplasty, Home regional, Fast track arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockProcedure or surgery
All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block | Experimental | 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. Receives: Procedure: Adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria
Measured: 24 hours
Secondary outcomes (4)
first 24 hour pain scores
Measured: 24 hours
first 96 hour pain scores
Measured: 96 hours
Rescue analgesic frequency
Measured: 24 hours
total analgesic usage in the first 24 and 96 postoperative hours
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugantha Ganapathy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228759
- Sponsor's protocol ID
- 105097
- Status last verified
- Mar 2017
- First submitted
- 18 Aug 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18362603
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT02228759
- Acronym / sponsor ID
- 105097
- Conditions
- Knee Osteoarthritis
- Keywords
- Ambulatory home regional, adductor canal block, Postoperative pain, total knee arthroplasty, Home regional, Fast track arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block | Experimental | Procedure: Adductor canal blockThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and females of 40-70years of age
- Scheduled to undergo unilateral primary total knee arthroplasty
- ASA Class I, II
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adductor canal blockAll patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block | Procedure or surgery | Adductor canal block |
Primary outcome
percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria
Time frame: 24 hours
4 secondary outcomes
first 24 hour pain scores
Time frame: 24 hours
first 96 hour pain scores
Time frame: 96 hours
Rescue analgesic frequency
Time frame: 24 hours
total analgesic usage in the first 24 and 96 postoperative hours
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Background: PubMed 18362603Ilfeld 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor canal block in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.