Clinical trial NCT02295124: Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Official title: Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Keywords: Nausea
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The occurrence of postoperative nausea
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes:
measure: Daily pain scores
timeFrame: 72 hours after surgery
measure: Incidence of opioid related itching
timeFrame: 72 hours after surgery
measure: Incidence of delirium
timeFrame: 72 hours after surgery
measure: Cumulative in-hospital opioid consumption
timeFrame: 72 hours after surgery
measure: Use of anti-nausea medications
timeFrame: 72 hours after surgery
measure: Cumulative drug costs per patient
timeFrame: 72 hours after surgery
measure: Post-operative admission duration
timeFrame: Total admission duration, an expected average of 72 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto. University Health Network. Toronto Western Hospital.
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.