Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

Sponsors

Lead sponsor: University Health Network, Toronto

Source 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.

Overall Status Completed
Start Date August 2012
Completion Date January 2016
Primary Completion Date January 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The occurrence of postoperative nausea Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary Outcome
Measure Time Frame
Daily pain scores 72 hours after surgery
Incidence of opioid related itching 72 hours after surgery
Incidence of delirium 72 hours after surgery
Cumulative in-hospital opioid consumption 72 hours after surgery
Use of anti-nausea medications 72 hours after surgery
Cumulative drug costs per patient 72 hours after surgery
Post-operative admission duration Total admission duration, an expected average of 72 hours
Enrollment 200
Condition
Intervention

Intervention type: Drug

Intervention name: Oxycodone

Description: Patients will receive oxycodone 10mg (5mg if > 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Arm group label: Oxycodone

Other name: Supeudol

Intervention type: Drug

Intervention name: Hydromorphone

Description: Patients will receive an initial dose of hydromorphone 2mg (1mg if > 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Arm group label: Hydromorphone

Other name: Palladone, Dilaudid

Eligibility

Criteria:

Inclusion Criteria:

- American Society of Anesthesiologists Physical Status Classification System 1-3

- Age 18-85 years

- Patients undergoing hip replacement surgery under spinal anesthesia

Exclusion Criteria:

- 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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Richard Brull, MD Principal Investigator University of Toronto. University Health Network. Toronto Western Hospital.
Location
facility
Toronto Western Hospital
Location Countries

Canada

Verification Date

November 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Oxycodone

Arm group type: Active Comparator

Description: 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.

Arm group label: Hydromorphone

Arm group type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov