Post-Dural Puncture HeadacheNCT02984618
Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
A study testing Sphenopalatine ganglion block and Epidural blood patch in people with Post-Dural Puncture Headache, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Sphenopalatine ganglion block and Epidural blood patch
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2016to 20 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic criteria for post dural puncture headache
- Moderate to severe post dural puncture headache
Who cannot join
- Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.
- Follow up loss
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário de Brasilia
Brasília, Federal District, 70000000
About this study
Official title: Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome
Read the detailed description
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Sphenopalatine ganglion block, Epidural blood patch
- 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.
Sphenopalatine ganglion blockProcedure or surgery
Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
Epidural blood patchProcedure or surgery
Autologous sterile blood (20ml) will be infused in the lombar epidural space.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side Receives: Procedure: Sphenopalatine ganglion block |
| Control group | Active comparator | Patients will receive classic epidural blood patch with 20ml of autologous blood Receives: Procedure: Epidural blood patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.
Measured: Pain reduction to no pain or low pain within 30 minutes of the intervention.
Secondary outcomes (3)
Tinitus
Measured: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Low back pain
Measured: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Sore throat
Measured: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Why it stopped: High recurrence of headache in SPG group.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimaraes, MsC, MD, Principal investigator, Universidade de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984618
- Sponsor's protocol ID
- CAAE: 60693416.0.0000.5558
- Status last verified
- Feb 2020
- First submitted
- 3 Dec 2016
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02984618
- Acronym / sponsor ID
- CAAE: 60693416.0.0000.5558
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High recurrence of headache in SPG group.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 7 Dec 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.
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome
Detailed description
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Sphenopalatine ganglion blockPatients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side |
| Control group | Active comparator | Procedure: Epidural blood patchPatients will receive classic epidural blood patch with 20ml of autologous blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnostic criteria for post dural puncture headache
- Moderate to severe post dural puncture headache
Key exclusion criteria (2 listed)
- Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.
- Follow up loss
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 |
|---|---|---|
| Sphenopalatine ganglion blockCotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators. | Procedure or surgery | Treatment group |
| Epidural blood patchAutologous sterile blood (20ml) will be infused in the lombar epidural space. | Procedure or surgery | Control group |
Primary outcome
Pain relief
Time frame: Pain reduction to no pain or low pain within 30 minutes of the intervention.
Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.
3 secondary outcomes
Tinitus
Time frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Low back pain
Time frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Sore throat
Time frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Results and safety
The study was stopped early (reason given: High recurrence of headache in SPG group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Gabriel MN Guimaraes, MsC, MD principal investigator
Universidade de Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine ganglion block and Epidural blood patch in people with Post-Dural Puncture Headache, run by Brasilia University Hospital at 1 site in Brazil.
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 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 28 Feb 2020. 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 Brazil. 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: High recurrence of headache in SPG group.). 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?
Pain relief (time frame: Pain reduction to no pain or low pain within 30 minutes of the intervention.). 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 28 Feb 2020.