Intra-Operative Adductor Canal Blocks
A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Sanjula Costa
- Phone Number: 72640 613-737-8899
- Email: scosta@ohri.ca
Study Locations
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-
Ontario
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Ottawa, Ontario, Canada
- The Ottawa Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients aged 18 years or older
- Primary TKA booked as SDD
- Diagnosis of osteoarthritis
Exclusion Criteria:
- Inability or refusal to sign informed consent form
- Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
- Non-osteoarthritis primary diagnosis
- Allergy to analgesic medications
- Contraindication to spinal and/or regional anaesthesia
- Any use of opioid pain medication within four weeks of the index procedure(13)
- Pain catastrophizing scale score ≥16 (8, 9, 14)
- History of cirrhosis
- History renal insufficiency
- History or sensory and/or motor neuropathy to the ipsilateral limb
- Simultaneous, bilateral TKA
- Non-TKA prosthesis
- Scheduled for non-SDD TKA.
- Preoperative varus/valgus of >10 degrees.
- Planned General Anaesthetic
- Use of Intrathecal Morphine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Anesthesiologist-Performed Adductor Canal Block (aACB)
Patients will get a pre-operative adductor canal block performed by an anesthesiologist.
|
The patient will undergo a pre-operative single-shot, ultrasound-guided ACB performed by an anaesthesiologist skilled in regional anaesthesia techniques.
The ACB will be performed in a dedicated block room, immediately prior to administration of a spinal anaesthetic.
|
|
Experimental: Surgeon-Performed Adductor Canal Block (sACB)
Patients will get an intra-operative adductor canal block performed by the surgeon
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The patient will undergo an intraoperative single-shot ACB performed by the treating surgeon following placement of the TKA components.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Report Pain
Time Frame: Up to 24 hours
|
Mean Numerical Pain Rating Scale (NPRS) scores on discharge
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Up to 24 hours
|
|
Pain medication use
Time Frame: When spinal anesthesia resolves until 24 hours after surgery
|
morphine equivalents of pain medication
|
When spinal anesthesia resolves until 24 hours after surgery
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to discharge
Time Frame: From PACU to discharge
|
Post-operative time in minutes to discharge home
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From PACU to discharge
|
|
Admission to Hospital
Time Frame: Up to 24 hours post-operative
|
Failure to discharge home requiring admission
|
Up to 24 hours post-operative
|
|
Readmission Rate
Time Frame: Up to 24 hours post-operative
|
Number of patients readmitted to the hospital within 24 hours
|
Up to 24 hours post-operative
|
|
Timed Up and Go Test
Time Frame: At discharge
|
Time is takes, in seconds, to stand, walk 3m, turn around, walk back 3m, and sit back down
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At discharge
|
|
Patient Reported Quality of Recovery
Time Frame: At 24 hours post-operative
|
Score on the Quality of Recovery-15 questionnaire
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At 24 hours post-operative
|
|
Patient Reported Function
Time Frame: pre-operatively, at 2 weeks post-operative
|
Difference in scores on the Oxford knee score (questionnaire), rated from 0-48 with 48 being the best functional outcome and 0 being the worst
|
pre-operatively, at 2 weeks post-operative
|
|
Patient Reported Quality of Life
Time Frame: pre-operatively, at 2 weeks post-operative
|
Difference in scores on the EQ-5D-5L questionnaire (Euro Quality of Life, 5 Dimension, 5 Level), rated from 11111 - 55555, with 11111 being full health and 55555 being worst health
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pre-operatively, at 2 weeks post-operative
|
|
Patient Reported Global Health
Time Frame: pre-operatively, at 2 weeks post-operative
|
Difference in scores on the PROMIS-10 - Global Health (questionnaire), which generates T-scores.
Higher T-scores indicate better health.
|
pre-operatively, at 2 weeks post-operative
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Simon Garceau, MD, The Ottawa Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20220573-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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