NauseaPONVNCT04889534
Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients
An observational study of Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Vomiting, Pain, Postoperative
- What is being tested?
- Analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to oncological surgeries in a specialized Hospital
Who may be able to join
- patients submitted to oncological surgeries
Who cannot join
- refusal to sign the agreement term
- lack of information in the records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Predictive Factors for Nausea, Vomiting and Postoperative Acute Pain in Oncological Patients
1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours
Read the detailed description
Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.
- Conditions
- Nausea, Vomiting, Pain, Postoperative
- Being tested
- Analgesia
- Keywords
- nausea, vomiting, pain
- Medical subject headings
- Nausea, Vomiting, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalgesiaProcedure or surgery
Patients will be observed during postoperative period,
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
pain intensity was measured using descriptive and verbal number scale
Measured: 24 hours
Secondary outcomes (1)
side effects from analgesia
nausea, vomiting, pruritus and hypotension were measured during first 24 postoperative hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Hazem A Ashmawi, phD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889534
- Sponsor's protocol ID
- NP380/2013
- Acronym
- PONV
- Status last verified
- Feb 2015
- First submitted
- 9 Aug 2018
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee SY, Hung CJ, Chen CC, Wu CC. Survival analysis of postoperative nausea and vomiting in patients receiving patient-controlled epidural analgesia. J Chin Med Assoc. 2014 Nov;77(11):589-93. doi: 10.1016/j.jcma.2014.08.008. Epub 2014 Sep 22.
PubMed 25249302Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.
PubMed 19542791
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Factors for Nausea, Vomiting and Postoperative Acute Pain in Oncological Patients
- ClinicalTrials.gov ID
- NCT04889534
- Acronym / sponsor ID
- PONV / NP380/2013
- Conditions
- Nausea, Vomiting, Pain, Postoperative
- Keywords
- nausea, vomiting, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 May 2021 (actual)
- 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.
1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours
Detailed description
Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to oncological surgeries in a specialized Hospital
Key inclusion criteria (1 listed)
- patients submitted to oncological surgeries
Key exclusion criteria (2 listed)
- refusal to sign the agreement term
- lack of information in the records
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 |
|---|---|---|
| AnalgesiaPatients will be observed during postoperative period, | Procedure or surgery | – |
Primary outcome
Intensity of postoperative pain
Time frame: 24 hours
pain intensity was measured using descriptive and verbal number scale
1 secondary outcome
side effects from analgesia
Time frame: 24 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 17 May 2021.
- Background: PubMed 25249302Lee SY, Hung CJ, Chen CC, Wu CC. Survival analysis of postoperative nausea and vomiting in patients receiving patient-controlled epidural analgesia. J Chin Med Assoc. 2014 Nov;77(11):589-93. doi: 10.1016/j.jcma.2014.08.008. Epub 2014 Sep 22.
- Background: PubMed 19542791Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.
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Nausea, Vomiting
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.
Hazem A Ashmawi, phD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 1 inclusion and 2 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 17 May 2021. 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 Brazil. 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.
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?
Intensity of postoperative pain (time frame: 24 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 NCT04889534, which also lists 2 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 17 May 2021.