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Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880800
Recruitment Status : Unknown
Verified August 2016 by Naveed Siddiqui, Mount Sinai Hospital, Canada.
Recruitment status was:  Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Naveed Siddiqui, Mount Sinai Hospital, Canada

Brief Summary:
The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. The investigators assumed that with the multimodal analgesia regimen without the use of IVPCA will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Morphine as IVPCA Drug: Hydromorphone as IVPCA Drug: Morphine Drug: Hydromorphone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Analgesia, patient controlled
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Drug: 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

Other Name: Morphine

Drug: 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.

Other Name: Dilaudid

Active Comparator: Analgesia, as per needed
Patients will receive intravenous (IV) opioids as per needed.
Drug: Morphine
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)

Drug: Hydromorphone
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Other Name: Dilaudid




Primary Outcome Measures :
  1. Total amount of opioid consumption postoperatively [ Time Frame: Every 24 hours for up to 48 hours after randomization ]

Secondary Outcome Measures :
  1. Opioid related side effects. [ Time Frame: Every 24 hours for up to 48 hours after randomization ]
    Opioid-related Symptom Distress Scale Questionnaire

  2. Patient satisfaction [ Time Frame: Once at 48 hours after randomization ]

    Patient satisfaction scale as below:

    1. Very dissatisfied
    2. Dissatisfied
    3. Slightly dissatisfied
    4. Slightly satisfied
    5. Satisfied
    6. Very satisfied

  3. Pain scores measured at rest and movement [ Time Frame: Every 12 hours for up to 48 hours after randomization ]
    Based on verbal analogue scale (VAS) scoring system (0-10), where score of 0 refers to no pain and a score of 10 refers to the worst pain imaginable

  4. Length of stay in hospital [ Time Frame: One week ]
    The total number of days the study patient was admitted in the hospital for a medical reason



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female patients aged 18 to 80 years old
  • 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 on chronic (more than twice a week) opioid treatment including Tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880800


Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Naveed Siddiqui    416-586-5270    naveed.siddiqui@uhn.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada

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Responsible Party: Naveed Siddiqui, Assistant professor, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02880800    
Other Study ID Numbers: 16-0098-A
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Naveed Siddiqui, Mount Sinai Hospital, Canada:
Analgesia, Patient-Controlled
Analgesics, Opioid
Drug-Related Side Effects and Adverse Reactions
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Morphine
Hydromorphone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents