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

Duzce University

Status

Enrolling

Conditions

Post-Dural Puncture Headache

Treatments

Procedure: Spinal anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT06992063

drozlemersoy7

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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