Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment

Postdural Puncture Headache Clinical Trial

— PDPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394024
• Other study ID #: ILK-10-124
• Status: Completed
• Start date: November 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 31, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

18 years and over ASA risk score I - II - III Patients with body mass index (BMI <40 kg/m²) Patients undergoing spinal anesthesia

Exclusion Criteria:

ASA IV, V, concomitant severe cardiac, respiratory, hepatic, renal disease Patients who do not want spinal anesthesia Those who are allergic to the medications used Those with localized infection at the injection site Those who have coagulopathy and use anticoagulant drugs Those with a history of chronic pain (migraine, sinusitis, etc.) Those with alcohol and opioid addiction Psychiatric diseases and patients with communication difficulties Those with vertebra or chest wall abnormalities Those with obesity (BMI > 40 kg/m²)

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Soner Ozcan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postdural puncture headache frequency	After spinal anesthesia, patients will be monitored for postdural puncture headaches, and their frequency will be determined.	6 months
Primary	postdural puncture headache treatments	Postdural puncture headache treatments decided to be applied will be noted and the results will be evaluated.	6 months
Secondary	Relationship between postdural puncture headache and predisposing factors	Predisposing factors that play a role in the development of patients' headache will be evaluated separately with the data to be obtained (e.g. age, needle size, hydration, previous medical history, comorbities, practitioner's experience etc.)	6 months