Postdural Puncture HeadacheNCT05777694
Postdural Punction Headache After Ceserian Section
A study testing 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 and Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle in people with Postdural Puncture Headache and Regional Anesthesia Morbidity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache, Regional Anesthesia Morbidity, Pregnancy Related
- What is being tested?
- 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 and Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Basaksehir
About this study
Official title: 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.
Read the 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.
- Being tested
- 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
- Keywords
- cesarean section, obstetric anesthesia, spinal anaesthesia, postdural punction headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needleProcedure or surgery
the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needleProcedure or surgery
the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needleProcedure or surgery
the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 25 gauge spinal needle | Active comparator | 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) Receives: 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 |
| Group 2: 26 gauge spinal needle | Active comparator | 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) Receives: 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 |
| Group 3: 27 gauge spina needle | Active comparator | 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDPH and spinal needle
The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache.
Measured: 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 (1)
Treatment response of patients with PDPH
Response rate of patients with PDPH to conservative and medical treatment
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pospective randomize study
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Duygu Akyol, M.D, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777694
- Sponsor's protocol ID
- 2021-297
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be kept confidential.
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.
PubMed 34141426Lee 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.
PubMed 30070060Mowafy 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.
PubMed 33993346
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05777694
- Acronym / sponsor ID
- 2021-297
- Keywords
- cesarean section, obstetric anesthesia, spinal anaesthesia, postdural punction headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- pospective randomize study
| Arm | Type | Receives |
|---|---|---|
| Group 1: 25 gauge spinal needle | Active comparator | 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 needleGroup 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 | Active comparator | 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 needleGroup 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 | Active comparator | 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 needleGroup 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) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needlethe investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache | Procedure or surgery | Group 1: 25 gauge spinal needle, Group 2: 26 gauge spinal needle, Group 3: 27 gauge spina needle |
| Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needlethe investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache | Procedure or surgery | Group 1: 25 gauge spinal needle, Group 2: 26 gauge spinal needle, Group 3: 27 gauge spina needle |
| Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needlethe investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache | Procedure or surgery | Group 1: 25 gauge spinal needle, Group 2: 26 gauge spinal needle, Group 3: 27 gauge spina needle |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Results publication: PubMed 34141426Chekol 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 publication: PubMed 30070060Lee 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 publication: PubMed 33993346Mowafy 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.
- Individual participant dataSharing planned: No. Patient data will be kept confidential.
Related trials for Postdural Puncture Headache
Recruiting
Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
Cesarean Section, Postoperative Nausea and Vomiting (PONV)
RecruitingObservational study
Neutrophil to Lymphocyte Ratio and Postdural Headache
Preoperative Neutrophil-to-Lymphocyte Ratio (NLR), Postdural Puncture Headache
Not yet recruitingPhase 4
A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
Postdural Puncture Headache, Epidural Analgesia, Obstetric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Akyol, M.D principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle in people with Postdural Puncture Headache and Regional Anesthesia Morbidity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777694, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.