PainNCT01502540
Pain Prevalence After Major Craniotomy
An observational study of Pain and Craniotomy, run by Mahidol University at 1 site in Thailand.
Trial summary
Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Craniotomy
- How many people
- 302 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2010to Jan 2013
- 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: patient undergoing cranitomy
Who may be able to join
- Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)
- Age > 18 years
Who cannot join
- Emergency or trauma
- Need postoperative ventilatory support
- Cannot communication
- Psychosis
- Not adherence to the treatment protocol
- History of using benzodiazepine or addictive substance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Prevalence After Major Craniotomy in Siriraj Hospital
Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate.
In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy.
Read more
Objectives
Primary objective :
- To study incidence of moderate to severe pain during first 48 hours after craniotomy.
Secondary objectives :
- To determine risk factors for moderate to severe pain during first 48 hours after craniotomy
- To evaluate side effects and complications of postoperative craniotomy pain control
- To compare patient's expectation for pain management before and after surgery
- To determine patient's satisfaction for postoperative pain management
- Conditions
- Pain, Craniotomy
- Keywords
- pain, craniotomy
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of moderate to severe pain following major craniotomy
Measured: 48 hours
Secondary outcomes (1)
risk factors of moderate to severe pain following craniotomy.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502540
- Sponsor's protocol ID
- Si223/2011
- Other IDs
- 161/2554(EC1)
- Status last verified
- Jan 2013
- First submitted
- 29 Dec 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Prevalence After Major Craniotomy in Siriraj Hospital
- ClinicalTrials.gov ID
- NCT01502540
- Acronym / sponsor ID
- Si223/2011
- Conditions
- Pain, Craniotomy
- Keywords
- pain, craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Dec 2011 (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.
Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate.
In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy.
Objectives
Primary objective :
- To study incidence of moderate to severe pain during first 48 hours after craniotomy.
Secondary objectives :
- To determine risk factors for moderate to severe pain during first 48 hours after craniotomy
- To evaluate side effects and complications of postoperative craniotomy pain control
- To compare patient's expectation for pain management before and after surgery
- To determine patient's satisfaction for postoperative pain management
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
- patient undergoing cranitomy
Key inclusion criteria (2 listed)
- Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)
- Age > 18 years
Key exclusion criteria (6 listed)
- Emergency or trauma
- Need postoperative ventilatory support
- Cannot communication
- Psychosis
- Not adherence to the treatment protocol
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
incidence of moderate to severe pain following major craniotomy
Time frame: 48 hours
1 secondary outcome
risk factors of moderate to severe pain following craniotomy.
Time frame: 48 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 15 Jan 2013.
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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.
Sirilak Suksompong, MD principal investigator
Mahidol University
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 Pain and Craniotomy, 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 6 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 15 Jan 2013. 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?
incidence of moderate to severe pain following major craniotomy (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 15 Jan 2013.