Trial Outcomes & Findings for Postoperative Headache in Elective Surgery Patients (NCT NCT02374346)

NCT ID: NCT02374346

Last Updated: 2016-01-01

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 494 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-01-01

Participant Flow

Participant milestones

Measure	Elective Surgery Patients A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
Overall Study STARTED	494
Overall Study COMPLETED	446
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Measure	Elective Surgery Patients A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
Overall Study operated or discharged during weekend	48

Baseline Characteristics

Postoperative Headache in Elective Surgery Patients

Baseline characteristics by cohort

Measure	Elective Surgery Patients n=446 Participants All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	396 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants
Age, Continuous	42.8 years n=5 Participants
Sex: Female, Male Female	321 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants
Region of Enrollment Greece	446 participants n=5 Participants

PRIMARY outcome

Timeframe: 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"

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

Outcome measures

Measure	Elective Surgery Patients (Total Sample) n=446 Participants postoperative headache in elective surgery patients	Postoperative Headache Patients Without Headache History Factors for developing postoperative headache in patients without previous history of headache.
Frequency of Postoperative Headache in Elective Surgery Patients postoperative headache in total sample	126 participants	—
Frequency of Postoperative Headache in Elective Surgery Patients postop headache with no history of headache	37 participants	—
Frequency of Postoperative Headache in Elective Surgery Patients postop headache with previous history	89 participants	—

SECONDARY outcome

Timeframe: 6 months

Demographic, anaesthetic and surgical factors associated with postoperative headache

Outcome measures

Measure	Elective Surgery Patients (Total Sample) n=446 Participants postoperative headache in elective surgery patients	Postoperative Headache Patients Without Headache History n=218 Participants Factors for developing postoperative headache in patients without previous history of headache.
Factors Associated With Postoperative Headache smoking	79 participants	22 participants
Factors Associated With Postoperative Headache female gender	103 participants	32 participants
Factors Associated With Postoperative Headache sevoflurane administration	91 participants	27 participants
Factors Associated With Postoperative Headache intraoperative hypotension	98 participants	23 participants
Factors Associated With Postoperative Headache caffeine consumption	104 participants	34 participants

Adverse Events

Elective Surgery Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P. Matsota

Attikon Hospital

Phone: 00302105831000

Email: matsota@yahoo.gr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place