Pain, Postoperative
Conditions
Keywords
Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions
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.
Interventions
DRUGMorphine 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
DRUGHydromorphone 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.
DRUGMorphine
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
DRUGHydromorphone
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of opioid consumption postoperatively | Every 24 hours for up to 48 hours after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid related side effects. | Every 24 hours for up to 48 hours after randomization | Opioid-related Symptom Distress Scale Questionnaire |
| Patient satisfaction | 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 |
| Pain scores measured at rest and movement | 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 |
| Length of stay in hospital | One week | The total number of days the study patient was admitted in the hospital for a medical reason |
Countries
Canada
Outcome results
None listed