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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analgesia, patient controlled | Experimental | Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone. |
|
| Analgesia, as per needed | Active Comparator | Patients will receive intravenous (IV) opioids as per needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine as IVPCA | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of opioid consumption postoperatively | Every 24 hours for up to 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid related side effects. | Opioid-related Symptom Distress Scale Questionnaire | Every 24 hours for up to 48 hours after randomization |
| Patient satisfaction | Patient satisfaction scale as below:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Hydromorphone as IVPCA | Drug | 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 | Drug | IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h) |
|
| Hydromorphone | Drug | Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h) |
|
|
| Once at 48 hours after randomization |
| Pain scores measured at rest and movement | 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 | Every 12 hours for up to 48 hours after randomization |
| Length of stay in hospital | The total number of days the study patient was admitted in the hospital for a medical reason | One week |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D064419 | Chemically-Induced Disorders |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |