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Regional Anesthesia in Total Hip and Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Hip Osteoarthritis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bupivacaine
Ropivacaine
Mepivacaine
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing total hip or knee replacement

Exclusion Criteria:

  • Study refusal
  • Inability to provide consent
  • Contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis)
  • Bilateral surgery
  • Revision surgery
  • Pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent
  • Pregnancy
  • Not receiving preoperative adductor canal block for any reason
  • Contra-indication to multimodal analgesia (acetaminophen or NSAIDs)
  • Obstructive sleep apnea requiring extended PACU stay
  • History of severe postoperative nausea and vomiting

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Bupivacaine

    Ropivacaine

    Mepivacaine

    Arm Description

    The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

    The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

    The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

    Outcomes

    Primary Outcome Measures

    Compare the effectiveness of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine: proportion of patients with a failed spinal anesthetic
    Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.
    Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Total costs associated with the providers involved and the costs associated with the time spent in the hospital following surgery but before discharge will be combined to report the cost profile

    Secondary Outcome Measures

    Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Post-operative pain will be measured using a combination of the Visual Analogue Scale Pain Scores (VAS), time to first analgesic request in PACU, and recording post-operative opioid use.
    Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Safety parameters will be compared by recording Adverse Events (AE)
    Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Quality of the block will compared by combing the the duration of total sensory and motor blocks and the number of patients who do not achieve a block at time of incision.
    Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.

    Full Information

    First Posted
    December 20, 2019
    Last Updated
    August 5, 2022
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04257682
    Brief Title
    Regional Anesthesia in Total Hip and Knee Arthroplasty
    Official Title
    Comparing Efficacy and Safety of Three Regional Anesthesia Regimens in Total Hip and Knee Arthroplasty: A Double Blind Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    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
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to test whether the use of Ropivacaine and Mepivacaine are better in terms of effectiveness, cost, and safety than Bupivacaine as regional anesthetics in elective hip or knee replacement surgery.
    Detailed Description
    Advances in pain management, regional anesthesia, and focused rehabilitation have increased the popularity of outpatient total hip and knee arthroplasty in a select group of eligible patients. However, one of the main impediments to same-day discharge is the prolonged motor block post-spinal anesthesia, as patients are routinely kept in the post-anesthesia care unit (PACU) until they demonstrate that the spinal anesthesia has worn off. At The Ottawa Hospital, the standard treatment for people receiving anesthesia during a total arthroplasty is the use of the anaesthetic, Bupivacaine. Mepivacaine and Ropivacaine are alternative anaesthetics that are also in use at The Ottawa Hospital. They are growing in popularity as anaesthetics because they and allow quicker recovery time when compared to Bupivacaine. Bupivacaine results in a long-lasting sensory-motor block, meaning that in the area that the local anesthesia was used, there is no sensation and limited movement for long periods of time. During hip or knee replacement surgery, you may want to have no sensation and the inability to move your lower limbs. However, it is not ideal for after surgery where weakness in the legs puts a person at increased risk for falls. Therefore, hospitalization after surgery typically lasts for a longer duration. Mepivacaine and Ropivacaine have a shorter motor block duration, allowing for a potentially earlier hospital discharge.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
    Arm Title
    Ropivacaine
    Arm Type
    Active Comparator
    Arm Description
    The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
    Arm Title
    Mepivacaine
    Arm Type
    Active Comparator
    Arm Description
    The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Local Anesthetic
    Intervention Description
    Bupivacaine is a long-lasting dense sensory-motor block that can last up to four hours. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 6.75 mg to 8.25 mg for the knee, and 7.5 mg to 9 mg for the hip.
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Local Anesthetic
    Intervention Description
    Ropivacaine is a long-acting local anesthetic that is known for its differential sensory-motor block. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 9 mg to 11 mg for the knee, and 10 mg to 12 mg for the hip.
    Intervention Type
    Drug
    Intervention Name(s)
    Mepivacaine
    Other Intervention Name(s)
    Local Anesthetic
    Intervention Description
    Mepivacaine is an intermediate-acting local anesthetic producing shorting and motor-sparing blocks. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 40 mg to 50 mg for the knee, and 45 mg to 55 mg for the hip.
    Primary Outcome Measure Information:
    Title
    Compare the effectiveness of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine: proportion of patients with a failed spinal anesthetic
    Description
    Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.
    Time Frame
    Day of surgery
    Title
    Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Description
    Total costs associated with the providers involved and the costs associated with the time spent in the hospital following surgery but before discharge will be combined to report the cost profile
    Time Frame
    Hospital discharge, approximately 1 day
    Secondary Outcome Measure Information:
    Title
    Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Description
    Post-operative pain will be measured using a combination of the Visual Analogue Scale Pain Scores (VAS), time to first analgesic request in PACU, and recording post-operative opioid use.
    Time Frame
    Immediately after completion of surgery, every hour during PACU stay - approximately 3 hours, every 6 hours during hospital stay - approximately 1 day, 24 hours after surgery, one week post-operatively
    Title
    Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Description
    Safety parameters will be compared by recording Adverse Events (AE)
    Time Frame
    24 hours after surgery, one week post-operatively
    Title
    Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Description
    Quality of the block will compared by combing the the duration of total sensory and motor blocks and the number of patients who do not achieve a block at time of incision.
    Time Frame
    During surgery, PACU discharge - approximately 3 hours
    Title
    Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
    Description
    Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.
    Time Frame
    Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing total hip or knee replacement Exclusion Criteria: Study refusal Inability to provide consent Contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis) Bilateral surgery Revision surgery Pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent Pregnancy Not receiving preoperative adductor canal block for any reason Contra-indication to multimodal analgesia (acetaminophen or NSAIDs) Obstructive sleep apnea requiring extended PACU stay History of severe postoperative nausea and vomiting
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Faraj Abdallah
    Phone
    613-613-737-8899
    Ext
    71887
    Email
    fabdallah@toh.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meaghan Dufresne
    Phone
    613-737-8899
    Ext
    73032
    Email
    meadufresne@ohri.ca

    12. IPD Sharing Statement

    Learn more about this trial

    Regional Anesthesia in Total Hip and Knee Arthroplasty

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