An observational study in Post-Dural Puncture Headache, sponsored by Duzce University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Duzce University · Observational
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.
After obtaining informed consent, eligible patients will be included in the study. Demographic data and headache history will be recorded, and preoperative anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI).
In the operating room, patients will be monitored with electrocardiography, pulse oximetry, non-invasive blood pressure, and Pleth Variability Index (PVI) sensors. Baseline measurements, including peak heart rate (HR), peripheral oxygen saturation (SpO2), systolic (SBP) and diastolic blood pressure (DBP), mean arterial pressure (MAP) and PVI will be recorded. Measurements will be repeated at five-minute intervals for the first 30 minutes of the operation and at 15-minute intervals thereafter.
Following spinal anesthesia, procedural details such as the experience level of the practitioner, patient positioning, needle brand, type and size, number of attempts, puncture level, and anesthetic dose will be documented.
Patients 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.
125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.
This study's enrollment of 112 is below the median of 188 across 34 observational studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Duzce University is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
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Obstetric and non-obstetric female patients undergoing spinal anesthesia
Exclusion Criteria:
56 female obstetric patients undergoing spinal anesthesia
Procedure: Spinal anesthesia
56 female non-obstetric patients undergoing spinal anesthesia
Procedure: Spinal anesthesia
In both groups patients will undergo spinal anesthesia and be followed intra- and postoperatively in the context of postdural puncture headache
Headache development for patients who can read and write
Development of post-dural puncture headache will be assessed using the Numerical Rating Scale (NRS) NRS is a scale between 0 (no pain) and 10 (most severe pain the patient has ever felt in is/her life). It is suitable for patients who can read and write.
Time frame: 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
Development of post-dural puncture headache will be assessed using Wong-Baker Faces Pain Rating Scale. The Wong-Baker Faces Pain Rating Scale is a tool that uses a combination of faces and words to help a person effectively communicate the severity of their physical pain. It is suitable for patients who cannot read and write.
Time frame: 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
Preoperative anxiety
Preoperative anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). STAI is a test to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time frame: 1 time preoperatively in the premedication room
Contributing factors: The experience level of the practitioner
The experience level of the practitioner will be recorded once when dural puncture is performed. It will be assessed as "1-3 years, 3-5 years, 5-10 years and over 10 years of practice".
Time frame: 1 time intraoperatively
Contributing factors: The patient positioning
The patient position will be recorded once when dural puncture is performed. It will be assessed as "sitting position, lateral decubitus or prone position".
Time frame: 1 time intraoperatively
Contributing factors: The needle factors
Needle brand, type and size will be recorded once when dural puncture is performed.
Time frame: 1 time intraoperatively
Contributing factors: The number of puncture attempts
The number of attempts will be recorded once when dural puncture is performed.
Time frame: 1 time intraoperatively
Contributing factors: The puncture level
The vertebral level of dural puncture will be recorded once when dural puncture is performed.
Time frame: 1 time intraoperatively
Contributing factors: The anesthetic dose
The total dose of local anesthetic drug will be recorded once when spinal anesthesia is performed.
Time frame: 1 time intraoperatively
Plan to share: Undecided
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Duzce University