Postdural Punction Headache After Ceserian Section

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Pregnancy Related; Regional Anesthesia Morbidity; Postdural Puncture Headache

Treatments: Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle; Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle; Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle

Study type: Interventional

Funder types: Other

Identifiers

NCT05777694

2021-297

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 750 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Group 1: 25 gauge spinal needle

Active Comparator group

Description:

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)

Treatment:

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

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

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

Group 2: 26 gauge spinal needle

Active Comparator group

Description:

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)

Treatment:

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

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

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

Group 3: 27 gauge spina needle

Active Comparator group

Description:

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)

Treatment:

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

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

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