Headache after spinal anesthesia in pregnant and non-pregnant women
Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
Duzce University · NCT06992063
This study will try to see if the rate and severity of post-dural puncture headaches differ between pregnant (obstetric) and non-pregnant female patients having spinal anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Duzce University (other) |
| Locations | 1 site (Düzce, Düzce) |
| Trial ID | NCT06992063 on ClinicalTrials.gov |
What this trial studies
This observational study follows women aged 18–65 who receive spinal anesthesia for elective obstetric or non-obstetric surgery to compare how often and how severe post-dural puncture headaches (PDPH) occur in each group. Researchers will record demographic and headache history, measure preoperative anxiety with the STAI, and document procedural details such as needle type and number of attempts and anesthetist experience. Intraoperative vitals will be monitored and postoperative headache frequency and intensity will be measured using the Numerical Rating Scale and Wong–Baker scale, along with any medical consultations or complications. The study compares incidence, severity, and potential contributing factors between the obstetric and non-obstetric groups.
Who should consider this trial
Good fit: Women aged 18–65 with ASA physical status I or II who are scheduled for elective surgery under spinal anesthesia at Duzce University Faculty of Medicine are the ideal participants.
Not a fit: Patients with ASA III or higher, those requiring ICU admission, emergency surgeries, cognitive or communication impairments, conversions to general anesthesia, or those outside the 18–65 age range are unlikely to benefit from participation.
Why it matters
Potential benefit: If clear differences or risk factors are identified, clinicians could better recognize women at higher risk of PDPH and adjust technique or counseling to reduce headaches.
How similar studies have performed: Previous observational work has linked pregnancy, younger age, needle size, and multiple puncture attempts to higher PDPH rates, so similar approaches have shown associations though reported differences between obstetric and non-obstetric groups vary.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Düzce, Düzce
- Duzce University Faculty of Medicine — Düzce, Düzce, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Özlem Ersoy Karka, Ass. Prof.
- Email: drozlemersoy@gmail.com
- Phone: 00905337293978
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Dural Puncture Headache