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Completed

NCT Number: NCT06394024

Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Suleyman Demirel University

Isparta, 32200, Turkey (Türkiye)

About this study

Different anesthesia techniques are applied to patients undergoing surgery. These are general anesthesia and regional (Spinal, Epidural, peripheral nerve blocks, etc.) anesthesia applications. Today, regional anesthesia is the most frequently preferred anesthesia method by anesthesiologists due to its low side effects. Spinal anesthesia is the temporary stopping of nerve conduction with a local anesthetic solution injected into the cerebrospinal fluid. It is one of the most commonly used regional anesthesia techniques today.Important advantages of regional anesthesia include the patient's continued spontaneous breathing, preservation of oropharyngeal reflexes, continuation of analgesia in the postoperative period, early mobilization, and short hospital stay.Post-dural puncture headache (PDPH) is one of the most important complications of neuraxial blocks and lumbar interventions for cerebrospinal fluid (CSF) examination. The incidence of PDPH is significantly higher in young people than in the elderly, in women compared to men, and in pregnant women compared to the normal population.In our study, spinal anesthesia cases will be examined. Patients with headache will be identified. Patients' demographic data (age, height, body weight, gender, comorbidities), ASA (American Society of Anesthesiologists) score, operation type, presence of headache etiology, needle type and diameter used, number of interventions and procedures. level, amount of local anesthetic given, adjuvant drugs added, experience of the practitioner, amount of fluid given, date and time of headache onset, treatment and procedure complications will be monitored and recorded in the form.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. postdural puncture headache frequency

    Time frame: 6 months

    -rate of headache

  2. postdural puncture headache treatments

    Time frame: 6 months

    -rate of treatments,

  3. Number of patients receiving postdural puncture headache treatments

    Time frame: 6 months

    -number of participants

  4. is postdural puncture headache treatments successful?

    Time frame: 6 months

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

  5. number of patient having postdural puncture headache

    Time frame: 6 months

    -number of participants

Secondary outcomes

  1. Relationship between postdural puncture headache and predisposing factors

    Time frame: 6 months

    -rate of headache

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

    Time frame: 6 months

    -number of participants

Sponsors and collaborators

Lead sponsor

Mustafa Soner Ozcan

Other

Registry information

Official study title

Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment Applied in Patients Undergoing Spinal Anesthesia

Acronym: PDPH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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