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Pain Prevalence After Major Craniotomy

Pain Prevalence After Major Craniotomy in Siriraj Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01502540
Enrollment
302
Registered
2011-12-30
Start date
2010-10-31
Completion date
2013-01-31
Last updated
2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy, Pain

Keywords

pain, craniotomy

Brief 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 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

Interventions

None listed

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery) * Age \> 18 years

Exclusion criteria

* Emergency or trauma * Need postoperative ventilatory support * Cannot communication * Psychosis * Not adherence to the treatment protocol * History of using benzodiazepine or addictive substance

Design outcomes

Primary

MeasureTime frame
incidence of moderate to severe pain following major craniotomy48 hours

Secondary

MeasureTime frame
risk factors of moderate to severe pain following craniotomy.48 hours

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026