NauseaPhase 4NCT02295124
Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
A Phase 4 study testing Oxycodone and Hydromorphone in people with Nausea, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nausea
- What is being tested?
- Oxycodone and Hydromorphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status Classification System 1-3
- Age 18-85 years
- Patients undergoing hip replacement surgery under spinal anesthesia
Who cannot join
- 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
Show all 9Show fewer
- pregnancy
- history of drug addiction
- history of major psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.
Read the 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.
- Conditions
- Nausea
- Being tested
- Oxycodone, Hydromorphone
- Keywords
- Nausea
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Supeudol
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.
HydromorphoneDrug
Also called Palladone, Dilaudid
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | 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. Receives: Drug: Oxycodone |
| Hydromorphone | Active comparator | 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. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of postoperative nausea
The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes (7)
Daily pain scores
Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively
Measured: 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
Measured: 72 hours after surgery
Incidence of delirium
The presence of delirium will be recorded until 72 hours post-operatively
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Total admission duration, an expected average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, University of Toronto. University Health Network. Toronto Western Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295124
- Sponsor's protocol ID
- 12-0267-AE
- Status last verified
- Nov 2017
- First submitted
- 11 Feb 2013
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10475299Pavlin 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.
PubMed 9768776Hartrick 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.
PubMed 19302899
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT02295124
- Acronym / sponsor ID
- 12-0267-AE
- Conditions
- Nausea
- Keywords
- Nausea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Drug: OxycodonePatients 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. |
| Hydromorphone | Active comparator | Drug: HydromorphonePatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status Classification System 1-3
- Age 18-85 years
- Patients undergoing hip replacement surgery under spinal anesthesia
Key exclusion criteria (9 listed)
- patient refusal
- contraindication or refusal of spinal anesthesia
- inability to provide informed consent
- history of dementia
- intolerance or allergy to oxycodone or hydromorphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneAlso: SupeudolPatients 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. | Drug | Oxycodone |
| HydromorphoneAlso: Palladone, DilaudidPatients 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. | Drug | Hydromorphone |
Primary outcome
The occurrence of postoperative nausea
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively
7 secondary outcomes
Daily pain scores
Time frame: 72 hours after surgery
Incidence of opioid related itching
Time frame: 72 hours after surgery
Incidence of delirium
Time frame: 72 hours after surgery
Cumulative in-hospital opioid consumption
Time frame: 72 hours after surgery
Use of anti-nausea medications
Time frame: 72 hours after surgery
Cumulative drug costs per patient
Time frame: 72 hours after surgery
Post-operative admission duration
Time frame: Total admission duration, an expected average of 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 10475299Macario 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.
- Background: PubMed 9768776Pavlin 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.
- Background: PubMed 19302899Hartrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brull, MD principal investigator
University of Toronto. University Health Network. Toronto Western Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone and Hydromorphone in people with Nausea, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of postoperative nausea (time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295124, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.