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

NCT06992063 | Completed

• 1 other identifier: drozlemersoy7
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (2)

• Headache development for patients who can read and write

  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.

  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

• Headache development for patients who cannot read and write

  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.

  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 (7)

• 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 needle factors

  1 time intraoperatively

• Contributing factors: The number of puncture attempts

  1 time intraoperatively

Study Arms (2)

Obstetric

56 female obstetric patients undergoing spinal anesthesia

Procedure: Spinal anesthesia

Non-obstetric

56 female non-obstetric patients undergoing spinal anesthesia

Procedure: Spinal anesthesia

Interventions

Spinal anesthesia PROCEDURE

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

Non-obstetric; Obstetric

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obstetric and non-obstetric female patients undergoing spinal anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine

Düzce, Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Özlem Ersoy Karka

  Düzce University Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 28, 2025
• Study Start: May 30, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)