Postoperative Headache in Elective Surgery Patients

Drug Withdrawal Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374346
• Other study ID #: 8/11/2004
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: November 29, 2015
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2015
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Withdrawal Headache
• Headache
• Substance Withdrawal Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months	No
Secondary	Factors Associated With Postoperative Headache	Demographic, anaesthetic and surgical factors associated with postoperative headache	6 months	No