Postdural Punction Headache After Ceserian Section

Not Applicable

Completed

• Conditions: Pregnancy Related; Regional Anesthesia Morbidity; Postdural Puncture Headache
• Interventions: 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; Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle

• Registration Number: NCT05777694
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Study First Submitted: 2023-02-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 25 gauge spinal needle	Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle	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 1: 25 gauge spinal needle	Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle	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: 26 gauge spinal needle	Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle	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: 27 gauge spina needle	Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle	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)
Group 1: 25 gauge spinal needle	Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle	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: 26 gauge spinal needle	Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle	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: 27 gauge spina needle	Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle	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)
Group 2: 26 gauge spinal needle	Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle	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: 27 gauge spina needle	Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle	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)

Primary Outcome Measures

Name	Time	Method
PDPH and spinal needle	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 Outcome Measures

Name	Time	Method
Treatment response of patients with PDPH	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

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Basaksehir, Turkey