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Postoperative Headache in Elective Surgery Patients

Factors Associated With the Presence of Postoperative Headache in Elective Surgery Patients: a Prospective Single Center Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02374346
Enrollment
494
Registered
2015-02-27
Start date
2008-09-30
Completion date
2009-03-31
Last updated
2016-01-01

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

Conditions

Drug Withdrawal Headache

Brief summary

To evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients By multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. Participants were interviewed preoperatively and for five days postoperatively regarding the appearance of headache; while demographics, life style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative adverse effects in elective surgery patients are recorded.

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.

Interventions

None listed

Sponsors

Attikon Hospital
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Postoperative Headache in Elective Surgery Patients6 monthsThe observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.

Secondary

MeasureTime frameDescription
Factors Associated With Postoperative Headache6 monthsDemographic, anaesthetic and surgical factors associated with postoperative headache

Participant flow

Participants by arm

ArmCount
Elective Surgery Patients
All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
446
Total446

Withdrawals & dropouts

PeriodReasonFG000
Overall Studyoperated or discharged during weekend48

Baseline characteristics

CharacteristicElective Surgery Patients
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
50 Participants
Age, Categorical
Between 18 and 65 years
396 Participants
Age, Continuous42.8 years
Region of Enrollment
Greece
446 participants
Sex: Female, Male
Female
321 Participants
Sex: Female, Male
Male
125 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Frequency of Postoperative Headache in Elective Surgery Patients

The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.

Time frame: 6 months

Population: Frequency of postoperative headache in total sample (n=446), Post-op Headache, no History of Headache (n=229), Post-op Headache, History of Headache (n=217), where n= number of participants analyzed

ArmMeasureGroupValue (NUMBER)
Elective Surgery Patients (Total Sample)Frequency of Postoperative Headache in Elective Surgery Patientspostoperative headache in total sample126 participants
Elective Surgery Patients (Total Sample)Frequency of Postoperative Headache in Elective Surgery Patientspostop headache with no history of headache37 participants
Elective Surgery Patients (Total Sample)Frequency of Postoperative Headache in Elective Surgery Patientspostop headache with previous history89 participants
Secondary

Factors Associated With Postoperative Headache

Demographic, anaesthetic and surgical factors associated with postoperative headache

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Elective Surgery Patients (Total Sample)Factors Associated With Postoperative Headachesevoflurane administration91 participants
Elective Surgery Patients (Total Sample)Factors Associated With Postoperative Headachesmoking79 participants
Elective Surgery Patients (Total Sample)Factors Associated With Postoperative Headacheintraoperative hypotension98 participants
Elective Surgery Patients (Total Sample)Factors Associated With Postoperative Headachecaffeine consumption104 participants
Elective Surgery Patients (Total Sample)Factors Associated With Postoperative Headachefemale gender103 participants
Postoperative Headache Patients Without Headache HistoryFactors Associated With Postoperative Headachecaffeine consumption34 participants
Postoperative Headache Patients Without Headache HistoryFactors Associated With Postoperative Headachefemale gender32 participants
Postoperative Headache Patients Without Headache HistoryFactors Associated With Postoperative Headachesevoflurane administration27 participants
Postoperative Headache Patients Without Headache HistoryFactors Associated With Postoperative Headacheintraoperative hypotension23 participants
Postoperative Headache Patients Without Headache HistoryFactors Associated With Postoperative Headachesmoking22 participants
Comparison: Sevoflurane administration in developing postoperative headachep-value: 0.00195% CI: [2.04, 5.13]t-test, 2 sided
Comparison: Smoking as a factor for developing postoperative headachep-value: 0.00695% CI: [1.19, 2.84]t-test, 2 sided
Comparison: Intraoperative hypotension associated with postoperative headache in total samplep-value: 0.00895% CI: [1.22, 3.66]t-test, 2 sided
Comparison: Female gender as a factor for developing postoperative headachep-value: 0.02495% CI: [1.08, 3.15]t-test, 2 sided
Comparison: Association of female gender and postoperative headachep-value: 0.00595% CI: [1.58, 13.17]t-test, 2 sided
Comparison: Association of intraoperative hypotension and postoperative headachep-value: 0.00695% CI: [1.48, 9.72]t-test, 2 sided
Comparison: Association of caffeine consumption and postoperative headachep-value: 0.04195% CI: [1.06, 14.06]t-test, 2 sided
Comparison: Association of sevoflurane administration and postoperative headachep-value: 0.00195% CI: [1.82, 9.95]t-test, 2 sided

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