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Completed

NCT Number: NCT06992063

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

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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Duzce University Faculty of Medicine

Düzce, 81000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia

Procedure

In both groups patients will undergo spinal anesthesia and be followed intra- and postoperatively in the context of postdural puncture headache

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Preoperative anxiety

    Time frame: 1 time preoperatively in the premedication room

    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.

  2. Contributing factors: The experience level of the practitioner

    Time frame: 1 time intraoperatively

    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".

  3. Contributing factors: The patient positioning

    Time frame: 1 time intraoperatively

    The patient position will be recorded once when dural puncture is performed. It will be assessed as "sitting position, lateral decubitus or prone position".

  4. Contributing factors: The needle factors

    Time frame: 1 time intraoperatively

    Needle brand, type and size will be recorded once when dural puncture is performed.

  5. Contributing factors: The number of puncture attempts

    Time frame: 1 time intraoperatively

    The number of attempts will be recorded once when dural puncture is performed.

  6. Contributing factors: The puncture level

    Time frame: 1 time intraoperatively

    The vertebral level of dural puncture will be recorded once when dural puncture is performed.

  7. Contributing factors: The anesthetic dose

    Time frame: 1 time intraoperatively

    The total dose of local anesthetic drug will be recorded once when spinal anesthesia is performed.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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