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Intra-Operative Adductor Canal Blocks

Primary Purpose

Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aACB
sACB
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Anesthesiologist-Performed Adductor Canal Block (aACB)

    Surgeon-Performed Adductor Canal Block (sACB)

    Arm Description

    Patients will get a pre-operative adductor canal block performed by an anesthesiologist.

    Patients will get an intra-operative adductor canal block performed by the surgeon

    Outcomes

    Primary Outcome Measures

    Patient Report Pain
    Mean Numerical Pain Rating Scale (NPRS) scores on discharge
    Pain medication use
    morphine equivalents of pain medication

    Secondary Outcome Measures

    Time to discharge
    Post-operative time in minutes to discharge home
    Admission to Hospital
    Failure to discharge home requiring admission
    Readmission Rate
    Number of patients readmitted to the hospital within 24 hours
    Timed Up and Go Test
    Time is takes, in seconds, to stand, walk 3m, turn around, walk back 3m, and sit back down
    Patient Reported Quality of Recovery
    Score on the Quality of Recovery-15 questionnaire
    Patient Reported Function
    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
    Patient Reported Quality of Life
    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
    Patient Reported Global Health
    Difference in scores on the PROMIS-10 - Global Health (questionnaire), which generates T-scores. Higher T-scores indicate better health.

    Full Information

    First Posted
    September 20, 2022
    Last Updated
    October 28, 2022
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Canadian Orthopaedic Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05601427
    Brief Title
    Intra-Operative Adductor Canal Blocks
    Official Title
    A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Canadian Orthopaedic Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Adductor canal blocks (ACB) have been recommended in total knee arthroplasty (TKA) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. ACB is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. Recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sACB) during surgery. However, there is currently very limited data on the clinical efficacy of such sACBs, and no studies assessing this technique in the context TKA that are discharged the same day. As such, this randomized control trial (RCT) is being done to compare sACBs to conventional anesthesiologist-performed adductor canal blocks (aACB).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Anesthesia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anesthesiologist-Performed Adductor Canal Block (aACB)
    Arm Type
    Active Comparator
    Arm Description
    Patients will get a pre-operative adductor canal block performed by an anesthesiologist.
    Arm Title
    Surgeon-Performed Adductor Canal Block (sACB)
    Arm Type
    Experimental
    Arm Description
    Patients will get an intra-operative adductor canal block performed by the surgeon
    Intervention Type
    Procedure
    Intervention Name(s)
    aACB
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    sACB
    Intervention Description
    The patient will undergo an intraoperative single-shot ACB performed by the treating surgeon following placement of the TKA components.
    Primary Outcome Measure Information:
    Title
    Patient Report Pain
    Description
    Mean Numerical Pain Rating Scale (NPRS) scores on discharge
    Time Frame
    Up to 24 hours
    Title
    Pain medication use
    Description
    morphine equivalents of pain medication
    Time Frame
    When spinal anesthesia resolves until 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Time to discharge
    Description
    Post-operative time in minutes to discharge home
    Time Frame
    From PACU to discharge
    Title
    Admission to Hospital
    Description
    Failure to discharge home requiring admission
    Time Frame
    Up to 24 hours post-operative
    Title
    Readmission Rate
    Description
    Number of patients readmitted to the hospital within 24 hours
    Time Frame
    Up to 24 hours post-operative
    Title
    Timed Up and Go Test
    Description
    Time is takes, in seconds, to stand, walk 3m, turn around, walk back 3m, and sit back down
    Time Frame
    At discharge
    Title
    Patient Reported Quality of Recovery
    Description
    Score on the Quality of Recovery-15 questionnaire
    Time Frame
    At 24 hours post-operative
    Title
    Patient Reported Function
    Description
    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
    Time Frame
    pre-operatively, at 2 weeks post-operative
    Title
    Patient Reported Quality of Life
    Description
    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
    Time Frame
    pre-operatively, at 2 weeks post-operative
    Title
    Patient Reported Global Health
    Description
    Difference in scores on the PROMIS-10 - Global Health (questionnaire), which generates T-scores. Higher T-scores indicate better health.
    Time Frame
    pre-operatively, at 2 weeks post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meaghan Dufresne
    Phone
    613-737-8899
    Ext
    74711
    Email
    meadufresne@ohri.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon Garceau, MD
    Organizational Affiliation
    The Ottawa Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Intra-Operative Adductor Canal Blocks

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