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

Study Overview
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Brief Summary
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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.

Official Title
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Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Morphine as IVPCA
* Drug: Hydromorphone as IVPCA
* Drug: Morphine
* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analgesia, patient controlled<br>Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone. | Drug: Morphine as IVPCA<br>* 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<br>* Other names: Morphine;Drug: Hydromorphone as IVPCA<br>* 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.<br>* Other names: Dilaudid;|
| Active Comparator: Analgesia, as per needed<br>Patients will receive intravenous (IV) opioids as per needed. | Drug: Morphine<br>* IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)<br>Drug: Hydromorphone<br>* Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)<br>* Other names: Dilaudid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of opioid consumption postoperatively |  | Every 24 hours for up to 48 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | 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: Very dissatisfied Dissatisfied Slightly dissatisfied Slightly satisfied Satisfied Very satisfied | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions