NCT06992063

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 112 (estimated)
• Sponsor: Duzce University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Dural Puncture Headache

Interventions

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

Timeline

• Start date: 2025-05-30
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-05-28
• Last updated: 2025-06-03

Locations

1 site across 1 country: Turkey (Türkiye)