- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374346
Postoperative Headache in Elective Surgery Patients
Factors Associated With the Presence of Postoperative Headache in Elective Surgery Patients: a Prospective Single Center Cohort Study
Study Overview
Status
Conditions
Detailed Description
A dedicated team interviewed patients preoperatively and during the first five postoperative days and collected data regarding medical history, surgery, anaesthesia and the presence of postoperative headache by manual record review. The frequency of preoperative headache was assessed by asking the subjects on the appearance or not of headache within the last year. Additional information were obtained to distinguish migraine which was deemed present only when the participants reported two or more of the following specific symptoms supporting this diagnosis as proposed by the International Headache Society; episodic headache (4-72 hours) with the following features: moderate or severe throbbing pain, worsened by movement, associated with nausea/vomiting, photophobia or phonophobia, with or without visual aura.
Specifically, preoperative data included patients' demographics, marital status, life-style and habits, as caffeine consumption (>200 mg/day or >2 cups of coffee/day), alcohol (drink equivalent > 15ml absolute alcohol) and tobacco consumption, previous experience or/and family history of headache. Intraoperative data included the type of anaesthesia (general, regional anaesthesia or their combination); anaesthetic drugs used; type and duration of surgery; intraoperative patients' position; and intraoperative adverse events including hypotension (decrease >20% from baseline), hypertension (increase >20% from baseline), hypercarbia (PaCO2 >6 kPa) and hypoxia (SpO2 <90%). Noticeably, the choice of anaesthetic technique and postoperative management were determined by the engaged anaesthesiologist.
Postoperative headache was defined as a dichotomous variable (i.e. present or not present) by asking the participants twice daily for the first five days (or less if discharged earlier) after anaesthesia and surgery.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Exclusion Criteria:
- patient refusal
- age under 18 years
- cognitive dysfunction
- head trauma or neurological disorders
- difficulty with language comprehension or any other inability to communicate verbally with the interviewer.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Postoperative Headache in Elective Surgery Patients
Time Frame: 6 months
|
The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factors Associated With Postoperative Headache
Time Frame: 6 months
|
Demographic, anaesthetic and surgical factors associated with postoperative headache
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8/11/2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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