Pain Prevalence After Major Craniotomy
2 other identifiers
observational
302
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 15, 2013
January 1, 2013
2.3 years
December 29, 2011
January 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of moderate to severe pain following major craniotomy
48 hours
Secondary Outcomes (1)
risk factors of moderate to severe pain following craniotomy.
48 hours
Eligibility Criteria
patient undergoing cranitomy
You may qualify if:
- Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)
- Age \> 18 years
You may not qualify if:
- Emergency or trauma
- Need postoperative ventilatory support
- Cannot communication
- Psychosis
- Not adherence to the treatment protocol
- History of using benzodiazepine or addictive substance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sirilak Suksompong
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sirilak Suksompong, MD
Mahidol University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 29, 2011
First Posted
December 30, 2011
Study Start
October 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 15, 2013
Record last verified: 2013-01