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Completed

NCT Number: NCT05777694

Postdural Punction Headache After Ceserian Section

The aim of this study is to compare the effect of spinal needle type on postdural puncture headache in patients who will undergo cesarean section.

The main question[s] it aims to answer are:

[Does spinal needle thickness affect postdural puncture headache?]

[What is the response of patients who develop postdural puncture headache to treatment?] In cases accepting cesarean section operation under spinal anesthesia, different tables were used with spinal needles, and it will be questioned whether headache will develop in the first 15 days postoperatively. Postdural puncture headache after surgery will be described.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache Pregnancy Related Regional Anesthesia Morbidity

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

About this study

Our study was designed as a prospective randomized study. Patients aged 20-50 years who accepted cesarean section under elective spinal anesthesia were included in the study. randomized into 3 groups with 250 patients in each group:

Group 1: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( Pencan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 2: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( Atraucan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 3: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( Pencan ® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Postdural puncture headache (PDPH) was evaluated by visiting patients who were discharged to the service after spinal anesthesia in the hospital for 24 hours, and by calling them within 15 days after discharge. Conservative and medical treatment was recommended for patients who developed PDPH, and the response of the patients to treatment was evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III

Exclusion criteria

  • Pregnant women who do not accept spinal anesthesia and who are contraindicated for spinal anesthesia Morbid obesity(BMI>40) Coagulopaty ASA 4 Clinically known local anesthetic allergy

Treatment and study plan

Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle

Procedure

the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle

Procedure

the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle

Procedure

the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Primary outcomes

  1. PDPH and spinal needle

    Time frame: postoperatively 15 days. The hospital was visited on the first day and information was obtained by calling in the following days. Patients with PDPH were evaluated as mild (1-3), moderate (4-7), severe (8-10) according to the Lybecker classification.

    The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache.

Secondary outcomes

  1. Treatment response of patients with PDPH

    Time frame: postoperatively 15 days, The hospital was visited on the first day and information was obtained by calling in the following days. Oral drugs used in the treatment and recommendations were noted.

    Response rate of patients with PDPH to conservative and medical treatment

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

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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