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

Primary Purpose

Nausea

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Oxycodone
Hydromorphone
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Nausea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oxycodone

Hydromorphone

Arm 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.

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.

Outcomes

Primary Outcome Measures

The occurrence of postoperative nausea
The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively

Secondary Outcome Measures

Daily pain scores
Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively
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
Incidence of delirium
The presence of delirium will be recorded until 72 hours post-operatively
Cumulative in-hospital opioid consumption
Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively
Use of anti-nausea medications
The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively
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
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

Full Information

First Posted
February 11, 2013
Last Updated
November 22, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02295124
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
Keywords
Nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone
Arm Type
Active Comparator
Arm 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 Title
Hydromorphone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Supeudol
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Palladone, Dilaudid
Intervention 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.
Primary Outcome Measure Information:
Title
The occurrence of postoperative nausea
Description
The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary Outcome Measure Information:
Title
Daily pain scores
Description
Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Incidence of opioid related itching
Description
The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Incidence of delirium
Description
The presence of delirium will be recorded until 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Cumulative in-hospital opioid consumption
Description
Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Use of anti-nausea medications
Description
The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Cumulative drug costs per patient
Description
The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively
Time Frame
72 hours after surgery
Title
Post-operative admission duration
Description
The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours
Time Frame
Total admission duration, an expected average of 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Brull, MD
Organizational Affiliation
University of Toronto. University Health Network. Toronto Western Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10475299
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.
Results Reference
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PubMed Identifier
9768776
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.
Results Reference
background
PubMed Identifier
19302899
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.
Results Reference
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Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

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