Clinical trial NCT06394024: Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
Official title: Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment Applied in Patients Undergoing Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postdural Puncture Headache
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years and over

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: postdural puncture headache frequency
timeFrame: 6 months
measure: postdural puncture headache treatments
timeFrame: 6 months
measure: Number of patients receiving postdural puncture headache treatments
timeFrame: 6 months
measure: is postdural puncture headache treatments successful?
timeFrame: 6 months
measure: number of patient having postdural puncture headache
timeFrame: 6 months
Secondary outcomes:
measure: Relationship between postdural puncture headache and predisposing factors
timeFrame: 6 months
measure: Number of patients obtained as a result of the relationship between postdural puncture headache and predisposing factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University
name: Mustafa Soner Mustafa Soner
role: PRINCIPAL_INVESTIGATOR
References: