Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea
Intervention: Oxycodone (Drug); Hydromorphone (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Richard Brull, MD, Principal Investigator, Affiliation: University of Toronto. University Health Network. Toronto Western Hospital.
Summary
The study aims to compare the incidence of side effects caused by Oxycodone and
Hydromorphone.
Clinical Details
Official title: Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The occurrence of postoperative nausea
Secondary outcome: Daily pain scoresIncidence of opioid related itching Incidence of delirium Cumulative in-hospital opioid consumption Use of anti-nausea medications Cumulative drug costs per patient Post-operative admission duration
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Toronto Western Hospital, Toronto, Ontario M5T 2S8, Canada
Additional Information
Related 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. 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. 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.
Starting date: August 2012
Last updated: May 27, 2015
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