Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
- Registration Number
- NCT02295124
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.
- Detailed Description
Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- American Society of Anesthesiologists Physical Status Classification System 1-3
- Age 18-85 years
- Patients undergoing hip replacement surgery under spinal anesthesia
- patient refusal
- contraindication or refusal of spinal anesthesia
- inability to provide informed consent
- history of dementia
- intolerance or allergy to oxycodone or hydromorphone
- chronic opioid use or chronic pain disorder
- pregnancy
- history of drug addiction
- history of major psychiatric illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydromorphone Hydromorphone Patients will be prescribed hydromorphone 2mg (1mg if \> age 65) every 2 hours as needed in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours. Oxycodone Oxycodone Patients will be prescribed oxycodone 10mg (5mg if \> age 65) every 2 hours as needed for post-operative pain management in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.
- Primary Outcome Measures
Name Time Method The occurrence of postoperative nausea Participants will be followed for the duration of hospital stay, an expected average of 72 hours The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively
- Secondary Outcome Measures
Name Time Method Incidence of opioid related itching 72 hours after surgery The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively
Incidence of delirium 72 hours after surgery The presence of delirium will be recorded until 72 hours post-operatively
Daily pain scores 72 hours after surgery Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively
Cumulative in-hospital opioid consumption 72 hours after surgery Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively
Use of anti-nausea medications 72 hours after surgery The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively
Cumulative drug costs per patient 72 hours after surgery The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively
Post-operative admission duration Total admission duration, an expected average of 72 hours The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours
Trial Locations
- Locations (1)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada