Post-Dural Puncture HeadacheNCT06992063
Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
An observational study of Post-Dural Puncture Headache, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstetric and non-obstetric female patients undergoing spinal anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine
Düzce, Düzce, 81000
About this study
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.
Read the detailed description
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.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Spinal anesthesia
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
In both groups patients will undergo spinal anesthesia and be followed intra- and postoperatively in the context of postdural puncture headache
| Study group | Role | What they receive |
|---|---|---|
| Obstetric | 56 female obstetric patients undergoing spinal anesthesia Receives: Procedure: Spinal anesthesia | |
| Non-obstetric | 56 female non-obstetric patients undergoing spinal anesthesia Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Secondary outcomes (7)
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.
Measured: 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".
Measured: 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".
Measured: 1 time intraoperatively
Contributing factors: The needle factors
Needle brand, type and size will be recorded once when dural puncture is performed.
Measured: 1 time intraoperatively
Contributing factors: The number of puncture attempts
The number of attempts will be recorded once when dural puncture is performed.
Measured: 1 time intraoperatively
Contributing factors: The puncture level
The vertebral level of dural puncture will be recorded once when dural puncture is performed.
Measured: 1 time intraoperatively
Contributing factors: The anesthetic dose
The total dose of local anesthetic drug will be recorded once when spinal anesthesia is performed.
Measured: 1 time intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start30 May 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ersoy Karka, Duzce University
- Investigators
- Özlem Ersoy Karka, Study chair, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992063
- Sponsor's protocol ID
- drozlemersoy7
- Status last verified
- May 2026
- First submitted
- 21 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
- ClinicalTrials.gov ID
- NCT06992063
- Acronym / sponsor ID
- drozlemersoy7
- Conditions
- Post-Dural Puncture Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstetric | – | Procedure: Spinal anesthesia56 female obstetric patients undergoing spinal anesthesia |
| Non-obstetric | – | Procedure: Spinal anesthesia56 female non-obstetric patients undergoing spinal anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstetric and non-obstetric female patients undergoing spinal anesthesia
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaIn both groups patients will undergo spinal anesthesia and be followed intra- and postoperatively in the context of postdural puncture headache | Procedure or surgery | Non-obstetric, Obstetric |
Primary outcome
Headache development 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
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.
Headache development 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
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.
7 secondary outcomes
Preoperative anxiety
Time frame: 1 time preoperatively in the premedication room
Contributing factors: The experience level of the practitioner
Time frame: 1 time intraoperatively
Contributing factors: The patient positioning
Time frame: 1 time intraoperatively
Contributing factors: The needle factors
Time frame: 1 time intraoperatively
Contributing factors: The number of puncture attempts
Time frame: 1 time intraoperatively
Contributing factors: The puncture level
Time frame: 1 time intraoperatively
Contributing factors: The anesthetic dose
Time frame: 1 time intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Ersoy Karka study chair
Düzce University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache development 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.