Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
NCT ID: NCT02880800
Last Updated: 2016-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Analgesia, patient controlled
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Morphine as IVPCA
Morphine as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of morphine as below:
Morphine bolus 1mg with a lockout interval of 5 minutes, no background infusion and maximum 30 mg in 4 hours
Hydromorphone as IVPCA
Hydromorphone as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of Hydromorphone as below:
Hydromorphone bolus 0.2 mg with a lockout interval of 5 minutes and a maximum dose of 6 mg in 4 hours.
Analgesia, as per needed
Patients will receive intravenous (IV) opioids as per needed.
Morphine
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
Hydromorphone
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Interventions
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Morphine as IVPCA
Morphine as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of morphine as below:
Morphine bolus 1mg with a lockout interval of 5 minutes, no background infusion and maximum 30 mg in 4 hours
Hydromorphone as IVPCA
Hydromorphone as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of Hydromorphone as below:
Hydromorphone bolus 0.2 mg with a lockout interval of 5 minutes and a maximum dose of 6 mg in 4 hours.
Morphine
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
Hydromorphone
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provision of written informed consent
* Patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only
* Patients with Body Mass Index (BMI) between 18 to 34.9
* Patients with American Society of Anesthesiologists (ASA) physical status classification of 1 to 3
Exclusion Criteria
* Patients with language barrier or difficulty in communication in English
* Patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen
* Patients with increased risk for respiratory depression with intrathecal morphine (OSA, central apnea)
* Patients with documented Renal or hepatic impairment
18 Years
80 Years
ALL
Yes
Sponsors
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Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Naveed Siddiqui
Assistant professor
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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16-0098-A
Identifier Type: -
Identifier Source: org_study_id
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