Post-Dural Puncture HeadacheNCT02827058
The Influence of Needle Diameter on Post Dural Puncture Headache
A study testing G25 pencil point needle and G27 pencil point needle in people with Post-Dural Puncture Headache, run by Helse Nord-Trøndelag HF at 3 sites in Norway.
Trial summary
The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- G25 pencil point needle and G27 pencil point needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesNorway
- Study dates
- Mar 2016to 1 May 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy
- pregnant
- spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
- informed consent
Who cannot join
- chronic headache
- (attempt to) epidural anesthesia
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Østfold Hospital
Fredrikstad
Study site
Fredrikstad
Levanger Hospital
Levanger
About this study
Official title: The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial
The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- G25 pencil point needle, G27 pencil point needle
- Keywords
- Delivery, obstetric, Analgesia, Epidural, Injections, Epidural, Needles, Cesarean Section
- Medical subject headings
- Post-Dural Puncture Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G25 pencil point needleDevice
G27 pencil point needleDevice
| Study group | Role | What they receive |
|---|---|---|
| G25 pencil point needle | Experimental | healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle Receives: Device: G25 pencil point needle |
| G27 pencil point needle | Active comparator | healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle Receives: Device: G27 pencil point needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of attempts until successful injection
Measured: 0 (injection time before delivery)
Secondary outcomes (1)
incidence of post dural puncture headache
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: due to difficulties recruiting patients and therefore too slow progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Ostfold
- Responsible party
- Sponsor
- Investigators
- Jan Sverre Vamnes, md, Study director, Østvold Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827058
- Sponsor's protocol ID
- 2016/140
- Status last verified
- Apr 2020
- First submitted
- 6 Jul 2016
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial
- ClinicalTrials.gov ID
- NCT02827058
- Acronym / sponsor ID
- 2016/140
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Delivery, obstetric, Analgesia, Epidural, Injections, Epidural, Needles, Cesarean Section
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to difficulties recruiting patients and therefore too slow progress
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Sykehuset Ostfold
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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 purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G25 pencil point needle | Experimental | Device: G25 pencil point needlehealthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle |
| G27 pencil point needle | Active comparator | Device: G27 pencil point needlehealthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- pregnant
- spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
- informed consent
Key exclusion criteria (2 listed)
- chronic headache
- (attempt to) epidural anesthesia
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 |
|---|---|---|
| G25 pencil point needle | Device | G25 pencil point needle |
| G27 pencil point needle | Device | G27 pencil point needle |
Primary outcome
number of attempts until successful injection
Time frame: 0 (injection time before delivery)
1 secondary outcome
incidence of post dural puncture headache
Time frame: 48 hrs
Results and safety
The study was stopped early (reason given: due to difficulties recruiting patients and therefore too slow progress). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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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.
Jan Sverre Vamnes, md study director
Østvold Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G25 pencil point needle and G27 pencil point needle in people with Post-Dural Puncture Headache, run by Helse Nord-Trøndelag HF at 3 sites in Norway.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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 was stopped early (reason given: due to difficulties recruiting patients and therefore too slow progress). Results are not available in the source record.
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?
number of attempts until successful injection (time frame: 0 (injection time before delivery)). 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 24 Apr 2020.