CompletedNot Applicable

Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery

Turkey (Türkiye)112 participantsStarted 2025-05-30

Plain-language summary

The goal of this observational study is to compare the incidence, severity, and potential risk factors for Post-dural Puncture headaches (PDPH) in obstetric and non-obstetric female patients undergoing spinal anesthesia. The main questions it aims to answer are: Are there differences between these two groups? Are there contributing factors? Researchers will compare obstetric and non-obstetric patients to see if pregnancy affects female patients in context of PDPH. Participants will be monitored periodically for PDPH development. The frequency and severity of headaches will be assessed using the Numerical Rating Scale (NRS) and Wong-Baker Scale. Additionally, the need for medical consultations and any complications arising from PDPH will be recorded.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients aged 18-65 years undergoing surgery under spinal anesthesia * Patients classified as ASA I or II according to the American Society of Anesthesiologists (ASA) classification Exclusion Criteria: * ASA III and above patients * Patients requiring Intensive Care Unit (ICU) admission * Patients with mental retardation * Patients with communication difficulties (e.g., hearing loss, speech impediments, language barriers) * Conversion to general anesthesia due to pain after spinal anesthesia * Emergency surgeries

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Headache development for patients who can read and write

Timeframe: 1 time preoperatively in the premedication unit, 1 time per hospitalization day postoperatively up to 7 days and on the 7th, 14th, 21st, and 30th postoperative days after discharge by phone call

Headache development for patients who cannot read and write

Trial details

NCT IDNCT06992063

SponsorDuzce University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-01

View on ClinicalTrials.gov More Post-Dural Puncture Headache trials