Post-Dural Puncture HeadachePhase 2NCT03430531
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
A Phase 2 study testing Lidocaine in people with Post-Dural Puncture Headache and Sphenopalatine Ganglion Block, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Dural Puncture Headache, Sphenopalatine Ganglion Block
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 11 Mar 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complains of symptoms suggestive of post-dural puncture headache
- Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
- Fluent in written and spoken English
Who cannot join
- Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
- Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
- Those who refuse to consent to participate in the study
- Patients who have had a failed epidural blood patch
- Cognitive Impairment
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).
Read the detailed description
The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :
- Number of subjects who get relief of pain
- The onset time to pain relief after application of block
- The duration of pain relief
- The incidence of recurrence of post-dural puncture headache
Secondary objectives are to:
- Monitor any complications due to SP ganglion block
- Measure patient satisfaction
- Monitor any residual effects at 1 months after the SP block
- Being tested
- Lidocaine
- 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.
LidocaineDrug
Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sphenopalatine ganglion block | Experimental | Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score at Baseline
Pain scores will be recorded at Baseline in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 15 minutes before the SP block
Pain Score 60 Minutes Post-SP Block
Pain scores will be recorded 60 minutes post-SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 60 minutes
Pain Score 1 Day Post-SP Block
Patient reported pain scores will be recorded day 1 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 1 day
Pain Score 2 Days Post-SP Block
Patient reported pain scores will be recorded day 2 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 2 days
Pain Score 7 Days Post-SP Block
Patient reported pain scores will be recorded day 7 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 7 days
Pain Score 30 Day Post-SP Block
Patient reported pain scores will be recorded day 30 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Measured: 30 days
Secondary outcomes (3)
Duration of Pain Relief
Patient reported how long after the SP block the patient reported pain scores that were decreased form the baseline measures. The outcome measure is measured in hours that pain relief was achieved.
Measured: 24 hours
Number of Participants With Recurrence of Post-dural Puncture Headache
Patient reported recurrence of post dural puncture headache resulting in treatment with epidural blood patch
Measured: 7 days
Number of Participants With Complications Due to SP Ganglion Block
Patients will be asked to report any side effects, including: allergic reaction to lidocaine, nose irritation and nose-bleed.
Measured: 15 minutes before the SP block to 30 days post SP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start31 May 2019
- Primary completion16 Jan 2020
- Study completion11 Mar 2022
Why it stopped: Study suspended and subsequently terminated due to Pandemic
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 Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single arm, pilot study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verghese T Cherian, MD, Milton S. Hershey Medical Center
- Investigators
- Verghese Cherian, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430531
- Sponsor's protocol ID
- 8426
- Status last verified
- May 2022
- First submitted
- 6 Feb 2018
- Last updated
- 15 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
- ClinicalTrials.gov ID
- NCT03430531
- Acronym / sponsor ID
- 8426
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended and subsequently terminated due to Pandemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 15 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).
Detailed description
The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :
- Number of subjects who get relief of pain
- The onset time to pain relief after application of block
- The duration of pain relief
- The incidence of recurrence of post-dural puncture headache
Secondary objectives are to:
- Monitor any complications due to SP ganglion block
- Measure patient satisfaction
- Monitor any residual effects at 1 months after the SP block
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single arm, pilot study
| Arm | Type | Receives |
|---|---|---|
| Sphenopalatine ganglion block | Experimental | Drug: LidocaineSphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complains of symptoms suggestive of post-dural puncture headache
- Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
- Fluent in written and spoken English
Key exclusion criteria (6 listed)
- Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
- Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
- Those who refuse to consent to participate in the study
- Patients who have had a failed epidural blood patch
- Cognitive Impairment
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 |
|---|---|---|
| LidocaineLidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes. | Drug | Sphenopalatine ganglion block |
Primary outcome
Pain Score at Baseline
Time frame: 15 minutes before the SP block
Pain scores will be recorded at Baseline in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 60 Minutes Post-SP Block
Time frame: 60 minutes
Pain scores will be recorded 60 minutes post-SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 1 Day Post-SP Block
Time frame: 1 day
Patient reported pain scores will be recorded day 1 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 2 Days Post-SP Block
Time frame: 2 days
Patient reported pain scores will be recorded day 2 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 7 Days Post-SP Block
Time frame: 7 days
Patient reported pain scores will be recorded day 7 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 30 Day Post-SP Block
Time frame: 30 days
Patient reported pain scores will be recorded day 30 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
3 secondary outcomes
Duration of Pain Relief
Time frame: 24 hours
Number of Participants With Recurrence of Post-dural Puncture Headache
Time frame: 7 days
Number of Participants With Complications Due to SP Ganglion Block
Time frame: 15 minutes before the SP block to 30 days post SP block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Verghese Cherian, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in people with Post-Dural Puncture Headache and Sphenopalatine Ganglion Block, run by Milton S. Hershey Medical Center 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 6 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 15 Jun 2022. 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2022). 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?
Pain Score at Baseline (time frame: 15 minutes before the SP block). The study lists 6 primary outcomes in all. 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 15 Jun 2022.