Postdural Puncture HeadachePhase 3NCT03652714
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache
A Phase 3 study testing Ganglion sphenopalatine block with local anesthetic in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by University Hospital Bispebjerg and Frederiksberg at 5 sites in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postdural Puncture Headache, Sphenopalatine Ganglion Block
- What is being tested?
- Ganglion sphenopalatine block with local anesthetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesDenmark
- Study dates
- 19 Sep 2018to 9 Sep 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
- Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
- Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations.
Who cannot join
- Patients who cannot cooperate to the study
- Patients who does not understand or speak Danish
- Allergy to the drugs used in the study
- Has taken opioids within 12 hours prior to intervention
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Rigshospitalet, University of Copenhagen
Copenhagen, 2100
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, 2400
Rigshospitalet Glostrup, University of Copenhagen
Glostrup Municipality, 2600
Herlev Hospital, University of Copenhagen
Herlev, 2730
Nordsjællands Hospital Hillerød
Hillerød, 3400
About this study
Official title: The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
Read the detailed description
Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).
Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.
If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.
- Being tested
- Ganglion sphenopalatine block with local anesthetic, Ganglion sphenopalatine block with placebo
- 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.
Ganglion sphenopalatine block with local anestheticProcedure or surgery
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
Ganglion sphenopalatine block with placeboProcedure or surgery
Block performed with bilaterally inserted q-tips with isotone NaCl
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic | Experimental | Not described Receives: Procedure: Ganglion sphenopalatine block with local anesthetic |
| Isotonic NaCl | Placebo comparator | Not described Receives: Procedure: Ganglion sphenopalatine block with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
Measured: 30 minutes after block
Secondary outcomes (5)
Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
Measured: 1 hour after block and 1 week after block
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
Measured: 30 minutes after block
Number of patients needing "rescue GSP-block"
Measured: During study period until completion of 1 week follow up
Number of patients needing a epidural blood patch
Measured: During study period until completion of 1 week follow up
Pain rating (0-100mm on a visual analogue scale, VAS) in supine position
Measured: 30 minutes after block, 1 hour after block and 1 week after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start19 Sep 2018
- Primary completion2 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652714
- Sponsor's protocol ID
- GSPB-2018
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
PubMed 32303377
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03652714
- Acronym / sponsor ID
- GSPB-2018
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 29 Aug 2018 (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 purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
Detailed description
Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).
Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.
If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic | Experimental | Procedure: Ganglion sphenopalatine block with local anesthetic |
| Isotonic NaCl | Placebo comparator | Procedure: Ganglion sphenopalatine block with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
- Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
- Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations.
Key exclusion criteria (4 listed)
- Patients who cannot cooperate to the study
- Patients who does not understand or speak Danish
- Allergy to the drugs used in the study
- Has taken opioids within 12 hours prior to intervention
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 |
|---|---|---|
| Ganglion sphenopalatine block with local anestheticBlock performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL. | Procedure or surgery | Local anesthetic |
| Ganglion sphenopalatine block with placeboBlock performed with bilaterally inserted q-tips with isotone NaCl | Procedure or surgery | Isotonic NaCl |
Primary outcome
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
Time frame: 30 minutes after block
Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
5 secondary outcomes
Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
Time frame: 1 hour after block and 1 week after block
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
Time frame: 30 minutes after block
Number of patients needing "rescue GSP-block"
Time frame: During study period until completion of 1 week follow up
Number of patients needing a epidural blood patch
Time frame: During study period until completion of 1 week follow up
Pain rating (0-100mm on a visual analogue scale, VAS) in supine position
Time frame: 30 minutes after block, 1 hour after block and 1 week after block
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 11 Sep 2019.
- Derived from this study: PubMed 32303377Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ganglion sphenopalatine block with local anesthetic in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by University Hospital Bispebjerg and Frederiksberg at 5 sites in Denmark.
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 4 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position. (time frame: 30 minutes after block). 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 NCT03652714, which also lists 1 linked publication.
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 11 Sep 2019.