Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment

NCT06394024 | Completed

• 1 other identifier: İLK-10-124
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Post-dural puncture headache (PDPH) is one of the most important complications of neuraxial blocks and lumbar interventions for cerebrospinal fluid (CSF) examination. It occurs due to tear in the dura mater and loss of cerebrospinal fluid (CSF) after intrathecal or epidural interventions.The incidence of PDPH depends on the thickness of the needle used and the type of tip. Headaches are more common with thick needles than with thin needles.In our study, postdural puncture headache in patients whose surgery was planned and spinal anesthesia was applied at Süleyman Demirel University faculty of medicine;frequency, predisposing factors, treatment intended to examine.

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (5)

• postdural puncture headache frequency

  -rate of headache

  6 months

• postdural puncture headache treatments

  -rate of treatments,

  6 months

• Number of patients receiving postdural puncture headache treatments

  -number of participants

  6 months

• is postdural puncture headache treatments successful?

  -success of treatment participants were also asked about the success of their treatment; the answer was yes or no.

  6 months

• number of patient having postdural puncture headache

  -number of participants

  6 months

Secondary Outcomes (2)

• Relationship between postdural puncture headache and predisposing factors

  6 months

• Number of patients obtained as a result of the relationship between postdural puncture headache and predisposing factors

  6 months

Study Arms (1)

POSTDURAL PUNCTURE HEADHECHE

We don't use drug

Eligibility Criteria

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

Study Population

18 years and over

You may qualify if:

• \>18 years
• ASA physical status class I, II and III
• BMI \<40 kg/m²
• Patients undergoing spinal anesthesia

You may not qualify if:

• ASA physical status class \> III
• Severe cardiac, respiratory, hepatic, and renal disease
• Refusing spinal anesthesia
• History of local anesthetic allergy
• Localized infection at the injection site
• Coagulopathy
• Anticoagulant drugs usage
• History of chronic pain (migraine, sinusitis, etc.)
• Alcohol and opioid addiction
• Psychiatric diseases
• Communication difficulties
• Vertebral or chest wall abnormalities
• BMI \> 40 kg/m²

Sponsors & Collaborators

• Mustafa Soner Ozcan: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Mustafa Soner Mustafa Soner

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 1, 2024
• Study Start: November 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)