Evaluation of Post-dural Puncture Headache in Female Patients Undergoing Obstetric and Non-obstetric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Headache development for patients who can read and write
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-obstetric
56 female non-obstetric patients undergoing spinal anesthesia
干预措施: Spinal anesthesia (Procedure)
Obstetric
56 female obstetric patients undergoing spinal anesthesia
干预措施: Spinal anesthesia (Procedure)
结局指标
主要结局
Headache development for patients who can read and write
时间窗: 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
时间窗: 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.
次要结局
- Contributing factors: The needle factors(1 time intraoperatively)
- Contributing factors: The puncture level(1 time intraoperatively)
- Contributing factors: The anesthetic dose(1 time intraoperatively)
- Preoperative anxiety(1 time preoperatively in the premedication room)
- Contributing factors: The experience level of the practitioner(1 time intraoperatively)
- Contributing factors: The patient positioning(1 time intraoperatively)
- Contributing factors: The number of puncture attempts(1 time intraoperatively)
研究者
Özlem Ersoy Karka
Assistant Professor
Duzce University