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Completed

NCT Number: NCT02374346

Postoperative Headache in Elective Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Factors Associated With Postoperative Headache

    Time frame: 6 months

    Demographic, anaesthetic and surgical factors associated with postoperative headache

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2015
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.