Clinical trial NCT06992063: Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
Official title: Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Dural Puncture Headache
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obstetric and non-obstetric female patients undergoing spinal anesthesia

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: 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
measure: Headache development for patients who cannot 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
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: 1 time preoperatively in the premedication room
measure: Contributing factors: The experience level of the practitioner
timeFrame: 1 time intraoperatively
measure: Contributing factors: The patient positioning
timeFrame: 1 time intraoperatively
measure: Contributing factors: The needle factors
timeFrame: 1 time intraoperatively
measure: Contributing factors: The number of puncture attempts
timeFrame: 1 time intraoperatively
measure: Contributing factors: The puncture level
timeFrame: 1 time intraoperatively
measure: Contributing factors: The anesthetic dose
timeFrame: 1 time intraoperatively
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University Faculty of Medicine
state: Düzce
Study officials:
affiliation: Düzce University Faculty of Medicine
name: Özlem Ersoy Karka
role: STUDY_CHAIR
References: