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Postdural Punction Headache After Ceserian Section

Primary Purpose

Postdural Puncture Headache, Regional Anesthesia Morbidity, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle
Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle
Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postdural Puncture Headache focused on measuring cesarean section, obstetric anesthesia, spinal anaesthesia, postdural punction headache

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Başakşehir Çam and Sakura City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1: 25 gauge spinal needle

Group 2: 26 gauge spinal needle

Group 3: 27 gauge spina needle

Arm 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)

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)

Outcomes

Primary Outcome Measures

PDPH and spinal needle
The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache.

Secondary Outcome Measures

Treatment response of patients with PDPH
Response rate of patients with PDPH to conservative and medical treatment

Full Information

First Posted
February 24, 2023
Last Updated
March 8, 2023
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05777694
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Regional Anesthesia Morbidity, Pregnancy Related
Keywords
cesarean section, obstetric anesthesia, spinal anaesthesia, postdural punction headache

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pospective randomize study
Masking
None (Open Label)
Masking Description
The prospective randomized study was randomized into 3 groups: 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)
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 25 gauge spinal needle
Arm Type
Active Comparator
Arm 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)
Arm Title
Group 2: 26 gauge spinal needle
Arm Type
Active Comparator
Arm 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)
Arm Title
Group 3: 27 gauge spina needle
Arm Type
Active Comparator
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle
Intervention Description
the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
Intervention Type
Procedure
Intervention Name(s)
Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle
Intervention Description
the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
Intervention Type
Procedure
Intervention Name(s)
Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle
Intervention Description
the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
Primary Outcome Measure Information:
Title
PDPH and spinal needle
Description
The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache.
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.
Secondary Outcome Measure Information:
Title
Treatment response of patients with PDPH
Description
Response rate of patients with PDPH to conservative and medical treatment
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Akyol, M.D
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Başakşehir Çam and Sakura City Hospital
City
Istanbul
State/Province
Basaksehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patient data will be kept confidential.
Citations:
PubMed Identifier
34141426
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.
Results Reference
result
PubMed Identifier
30070060
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.
Results Reference
result
PubMed Identifier
33993346
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.
Results Reference
result

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Postdural Punction Headache After Ceserian Section

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