Clinical trial NCT05777694: Postdural Punction Headache After Ceserian Section
Official title: Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postdural Puncture Headache
Regional Anesthesia Morbidity
Pregnancy Related
Keywords: cesarean section
obstetric anesthesia
spinal anaesthesia
postdural punction headache
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-21
Enrollment: 750
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pospective randomize study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: PDPH and spinal needle
timeFrame: 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 outcomes:
measure: Treatment response of patients with PDPH
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Basaksehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Akyol, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chekol B, Yetneberk T, Teshome D. Prevalence and associated factors of post dural puncture headache among parturients who underwent cesarean section with spinal anesthesia: A systemic review and meta-analysis, 2021. Ann Med Surg (Lond). 2021 Jun 2;66:102456. doi: 10.1016/j.amsu.2021.102456. eCollection 2021 Jun.
citation: Lee SI, Sandhu S, Djulbegovic B, Mhaskar RS. Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta-analysis. J Evid Based Med. 2018 Aug;11(3):136-144. doi: 10.1111/jebm.12311. Epub 2018 Aug 1.
citation: Mowafy SMS, Ellatif SEA. Effectiveness of nebulized dexmedetomidine for treatment of post-dural puncture headache in parturients undergoing elective cesarean section under spinal anesthesia: a randomized controlled study. J Anesth. 2021 Aug;35(4):515-524. doi: 10.1007/s00540-021-02944-6. Epub 2021 May 16.