Anesthesia; Adverse Effect, Spinal and Epidural, HeadacheNCT01821807
Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
An observational study of Anesthesia; Adverse Effect, Spinal and Epidural, Headache and Complications; Anesthesia, Spinal and Epidural, in Pregnancy, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients. Two kind of spinal anesthesia needles will be used: 1. 26 Gauge Quincke (cutting-tip needle) 2. 26 Gauge Atraucan (atraumatic needle) The investigators will observe: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural, Headache, Complications; Anesthesia, Spinal and Epidural, in Pregnancy
- How many people
- 256 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman University Research Hospital, Turkey.
Who may be able to join
- Pregnant female patients between 18-40 years old undergoing cesarean section
- Patient accepting spinal anesthesia
Who cannot join
- Infection at the spinal needle insertion cite
- Coagulability disorder
- Patient not accepting the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman
About this study
Official title: Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section, Two Different Needles.
The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.
Two kind of spinal anesthesia needles will be used:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
The investigators will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- Backache
Read the detailed description
It is a known phenomenon that spinal anesthesia sometimes results in headache.
The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.
Two kind of spinal anesthesia needles will be used:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
We will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- Backache
2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an observational study. Although literature gives different rates of postdural puncture headache for these two needles, we observe the same rate of headache in our clinical practice. We want to define the real rate of postdural puncture headache in patients undergoing cesarean section with spinal anesthesia.
- Conditions
- Anesthesia; Adverse Effect, Spinal and Epidural, Headache, Complications; Anesthesia, Spinal and Epidural, in Pregnancy
- Keywords
- spinal anesthesia, spinal needle, cesarean section, headache, backache
- Medical subject headings
- Headache, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 26 gauge quincke | Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. | |
| 26 gauge atraucan | Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section
Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.
Measured: 1 week
Secondary outcomes (1)
Backache in Patients Receiving Spinal Anesthesia for Cesarean Section
Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia; Adverse Effect, Spinal and Epidural, 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Adiyaman University Research Hospital
- Investigators
- Ruslan Abdullayev, Principal investigator, Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821807
- Sponsor's protocol ID
- PDPH 26Q26A
- Status last verified
- Jan 2014
- First submitted
- 27 Mar 2013
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section, Two Different Needles.
- ClinicalTrials.gov ID
- NCT01821807
- Acronym / sponsor ID
- PDPH 26Q26A
- Conditions
- Anesthesia; Adverse Effect, Spinal and Epidural, Headache, Complications; Anesthesia, Spinal and Epidural, in Pregnancy
- Keywords
- spinal anesthesia, spinal needle, cesarean section, headache, backache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 10 Dec 2013
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 the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.
Two kind of spinal anesthesia needles will be used:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
The investigators will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- Backache
Detailed description
It is a known phenomenon that spinal anesthesia sometimes results in headache.
The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.
Two kind of spinal anesthesia needles will be used:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
We will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- Backache
2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an observational study. Although literature gives different rates of postdural puncture headache for these two needles, we observe the same rate of headache in our clinical practice. We want to define the real rate of postdural puncture headache in patients undergoing cesarean section with spinal anesthesia.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 26 gauge quincke | – | –Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. |
| 26 gauge atraucan | – | –Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman University Research Hospital, Turkey.
Key inclusion criteria (2 listed)
- Pregnant female patients between 18-40 years old undergoing cesarean section
- Patient accepting spinal anesthesia
Key exclusion criteria (3 listed)
- Infection at the spinal needle insertion cite
- Coagulability disorder
- Patient not accepting the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section
Time frame: 1 week
Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.
1 secondary outcome
Backache in Patients Receiving Spinal Anesthesia for Cesarean Section
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ruslan Abdullayev principal investigator
Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect, Spinal and Epidural, Headache and Complications; Anesthesia, Spinal and Epidural, in Pregnancy, run by Adiyaman University Research 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 2 inclusion and 3 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 6 Mar 2014. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2014.