Postdural Punction Headache After Ceserian Section
Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study
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.
Study Overview
Status
Intervention / Treatment
- 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
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basaksehir
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Istanbul, Basaksehir, Turkey
- Başakşehir Çam and Sakura City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1: 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)
|
the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
|
|
Active Comparator: Group 2: 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)
|
the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
|
|
Active Comparator: Group 3: 27 gauge spina 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)
|
the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Duygu Akyol, M.D, Basaksehir Cam & Sakura Şehir Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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