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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 scores

Incidence 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

Page last updated: August 23, 2015

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