NCT04889534

Brief Summary

1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

August 9, 2018

Last Update Submit

May 14, 2021

Conditions

NauseaVomitingPain, Postoperative

Keywords

nauseavomitingpain

Outcome Measures

Primary Outcomes (1)

  • Intensity of postoperative pain

    pain intensity was measured using descriptive and verbal number scale

    24 hours

Secondary Outcomes (1)

  • side effects from analgesia

    24 hours

Interventions

AnalgesiaPROCEDURE

Patients will be observed during postoperative period,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients submitted to oncological surgeries in a specialized Hospital

You may qualify if:

  • patients submitted to oncological surgeries

You may not qualify if:

  • refusal to sign the agreement term
  • lack of information in the records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela Maria Sousa

São Paulo, São Paulo, 01403010, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 25249302BACKGROUND

  • Gramke 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.

    PMID: 19542791BACKGROUND

MeSH Terms

Conditions

NauseaVomitingPain, PostoperativePain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Hazem A Ashmawi, phD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2018

First Posted

May 17, 2021

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 17, 2021

Record last verified: 2015-02

Locations

BR(1)