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

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: Morphine as IVPCA; Drug: Morphine; Drug: Hydromorphone as IVPCA; Drug: Hydromorphone

• Registration Number: NCT02880800
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analgesia, patient controlled	Morphine as IVPCA	Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Analgesia, patient controlled	Hydromorphone as IVPCA	Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Analgesia, as per needed	Hydromorphone	Patients will receive intravenous (IV) opioids as per needed.
Analgesia, as per needed	Morphine	Patients will receive intravenous (IV) opioids as per needed.

Primary Outcome Measures

Name	Time	Method
Total amount of opioid consumption postoperatively	Every 24 hours for up to 48 hours after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada