Postoperative PainNCT00949429
Quality of Postoperative Pain Management in Cardiac Surgical Patients
An observational study of Postoperative Pain, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Feb 2011
- 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 scheduled for cardiac surgery in Siriraj Hospital
Who may be able to join
- patients scheduled for cardiac surgery in Siriraj Hospital
- age > 18
Who cannot join
- unable to communicate with the patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objectives
- To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively.
- To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients.
- To compare the preoperative pain expectation and postoperative pain experience in the same patient.
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, cardiac surgery, risk factors
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively
Measured: 48 hours
Secondary outcomes (2)
Risk factors of postoperative pain in cardiac surgical patients
Measured: 48 hours
Patient's preoperative pain expectation and postoperative pain experience
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Kasana Raksamani, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949429
- Sponsor's protocol ID
- Si306/2009
- Status last verified
- Jul 2011
- First submitted
- 29 Jul 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postoperative Pain Management in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT00949429
- Acronym / sponsor ID
- Si306/2009
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, cardiac surgery, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Jul 2009 (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 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.
Detailed description
Objectives
- To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively.
- To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients.
- To compare the preoperative pain expectation and postoperative pain experience in the same patient.
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 scheduled for cardiac surgery in Siriraj Hospital
Key inclusion criteria (2 listed)
- patients scheduled for cardiac surgery in Siriraj Hospital
- age > 18
Key exclusion criteria (1 listed)
- unable to communicate with the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively
Time frame: 48 hours
2 secondary outcomes
Risk factors of postoperative pain in cardiac surgical patients
Time frame: 48 hours
Patient's preoperative pain expectation and postoperative pain experience
Time frame: 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 22 Jul 2011.
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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.
Kasana Raksamani, MD principal investigator
Siriraj Hospital
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 Postoperative Pain, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 1 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 22 Jul 2011. 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 Thailand. 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?
Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2011.