NCT00949429

Brief Summary

The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

1.4 years

First QC Date

July 29, 2009

Last Update Submit

July 21, 2011

Conditions

Postoperative Pain

Keywords

postoperative paincardiac surgeryrisk factors

Outcome Measures

Primary Outcomes (1)

  • Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively

    48 hours

Secondary Outcomes (2)

  • Risk factors of postoperative pain in cardiac surgical patients

    48 hours

  • Patient's preoperative pain expectation and postoperative pain experience

    72 hours

Eligibility Criteria

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

patients scheduled for cardiac surgery in Siriraj Hospital

You may qualify if:

  • patients scheduled for cardiac surgery in Siriraj Hospital
  • age \> 18

You may not qualify if:

  • unable to communicate with the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kasana Raksamani, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

TH(1)