Postdural Punction Headache After Ceserian Section

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postdural Puncture Headache, Regional Anesthesia Morbidity, Pregnancy Related

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pospective randomize study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: 25 gauge spinal needle<br>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) | Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle<br>* the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle<br>* the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle<br>* the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>|
| Active Comparator: Group 2: 26 gauge spinal needle<br>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) | Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle<br>* the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle<br>* the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle<br>* the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>|
| Active Comparator: Group 3: 27 gauge spina needle<br>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) | Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle<br>* the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle<br>* the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle<br>* the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDPH and spinal needle | The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response of patients with PDPH | Response rate of patients with PDPH to conservative and medical treatment | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, obstetric anesthesia, spinal anaesthesia, postdural punction headache