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

The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.

Study Overview

• Status: Completed
• Conditions: Nausea
• Intervention / Treatment: Drug: Oxycodone; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Oxycodone; 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.; Other Names: Supeudol
Active Comparator: 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.	Drug: Hydromorphone; 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.; Other Names: Palladone, Dilaudid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of postoperative nausea	The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively	Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily pain scores	Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively	72 hours after surgery
Incidence of opioid related itching	The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively	72 hours after surgery
Incidence of delirium	The presence of delirium will be recorded until 72 hours post-operatively	72 hours after surgery
Cumulative in-hospital opioid consumption	Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively	72 hours after surgery
Use of anti-nausea medications	The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively	72 hours after surgery
Cumulative drug costs per patient	The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively	72 hours after surgery
Post-operative admission duration	The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours	Total admission duration, an expected average of 72 hours

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Richard Brull, MD, University of Toronto. University Health Network. Toronto Western Hospital.

Publications and helpful links

General Publications

• Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
• Pavlin DJ, Rapp SE, Polissar NL, Malmgren JA, Koerschgen M, Keyes H. Factors affecting discharge time in adult outpatients. Anesth Analg. 1998 Oct;87(4):816-26. doi: 10.1097/00000539-199810000-00014.
• Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Nausea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone; Hydromorphone
• Other Study ID Numbers: 12-0267-AE