Postdural Puncture HeadacheEarly Phase 1PDPHNCT02365909
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
A Early Phase 1 study testing 0.5% bupivacaine and normal saline in people with Postdural Puncture Headache, run by University of Arkansas at 1 site in United States.
Trial summary
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- 0.5% bupivacaine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2015to 30 Aug 2016
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
- Age ≥ 18 years.
- ASA physical status ≤ 3
Who cannot join
- Known coagulopathy
- Known nasal septal deviation or abnormalities
- Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.
- Conditions
- Postdural Puncture Headache
- Being tested
- 0.5% bupivacaine, normal saline
- 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.
0.5% bupivacaineDrug
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
normal salineDrug
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
| Study group | Role | What they receive |
|---|---|---|
| Acitve | Active comparator | This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® Receives: Drug: 0.5% bupivacaine |
| Placebo | Placebo comparator | This group will receive 0.3 ml of normal saline per nare, applied with the Tx360® Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache verbal pain score
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start29 Jun 2015
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Why it stopped: Study stopped due to difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365909
- Sponsor's protocol ID
- 203684
- Acronym
- PDPH
- Status last verified
- Sep 2017
- First submitted
- 11 Feb 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
- ClinicalTrials.gov ID
- NCT02365909
- Acronym / sponsor ID
- PDPH / 203684
- Conditions
- Postdural Puncture Headache
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to difficulty recruiting patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 19 Feb 2015 (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.
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acitve | Active comparator | Drug: 0.5% bupivacaineThis group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® |
| Placebo | Placebo comparator | Drug: normal salineThis group will receive 0.3 ml of normal saline per nare, applied with the Tx360® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
- Age ≥ 18 years.
- ASA physical status ≤ 3
Key exclusion criteria (3 listed)
- Known coagulopathy
- Known nasal septal deviation or abnormalities
- Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)
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 |
|---|---|---|
| 0.5% bupivacaineThis group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® | Drug | Acitve |
| normal salineThis group will receive 0.3 ml of normal saline per nare, applied with the Tx360® | Drug | Placebo |
Primary outcome
Headache verbal pain score
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Study stopped due to difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 0.5% bupivacaine and normal saline in people with Postdural Puncture Headache, run by University of Arkansas at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 18 Sep 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to difficulty recruiting patients). 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?
Headache verbal pain score (time frame: 1 hour). 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 18 Sep 2017.