HeadachePhase 4NCT02962427
Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
A Phase 4 study testing Sphenopalatine ganglion Block and Epidural blood patch in people with Headache, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Headache
- What is being tested?
- Sphenopalatine ganglion Block and Epidural blood patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 4
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years or age or greater
- Postpartum obstetric parturient who was previously admitted to UCH.
- Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders:
- Dural puncture has been performed
- Headache has developed within 5 days of the dural puncture
- Not better accounted for by another ICHD-3 diagnosis.
- Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally.
Who cannot join
- Refusal to participate in the study
- Placement of an EBP within the past 5 days
- Allergy and/or intolerance to any the study materials
- Contraindications to an EBP
- Plan for therapeutic anticoagulation post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.
Read the detailed description
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.
- Conditions
- Headache
- Being tested
- Sphenopalatine ganglion Block, Epidural blood patch
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine ganglion BlockDrug
Also called SGB
Epidural blood patchProcedure or surgery
Also called EBP
| Study group | Role | What they receive |
|---|---|---|
| Sphenopalatine Ganglion Block | Experimental | Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes. Receives: Drug: Sphenopalatine ganglion Block |
| Epidural blood patch | Active comparator | Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours. Receives: Procedure: Epidural blood patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Numerical Rating Scale Pain Score
The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score.
Measured: Baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Decided to participate in a multicenter trial researching the same issue
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 HeadacheStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Wood, M.D., Principal investigator, University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962427
- Sponsor's protocol ID
- 16-1596
- Status last verified
- Jan 2020
- First submitted
- 9 Nov 2016
- Last updated
- 23 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Not sharing IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.
- ClinicalTrials.gov ID
- NCT02962427
- Acronym / sponsor ID
- 16-1596
- Conditions
- Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decided to participate in a multicenter trial researching the same issue
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 23 Jan 2020
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 research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.
Detailed description
The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphenopalatine Ganglion Block | Experimental | Drug: Sphenopalatine ganglion BlockSphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes. |
| Epidural blood patch | Active comparator | Procedure: Epidural blood patchEpidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 years or age or greater
- Postpartum obstetric parturient who was previously admitted to UCH.
- Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders:
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Placement of an EBP within the past 5 days
- Allergy and/or intolerance to any the study materials
- Contraindications to an EBP
- Plan for therapeutic anticoagulation post-partum
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 BlockAlso: SGB | Drug | Sphenopalatine Ganglion Block |
| Epidural blood patchAlso: EBP | Procedure or surgery | Epidural blood patch |
Primary outcome
Change in The Numerical Rating Scale Pain Score
Time frame: Baseline and 48 hours
The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not sharing IPD with other researchers
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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.
Cristina Wood, M.D. principal investigator
University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sphenopalatine ganglion Block and Epidural blood patch in people with Headache, run by University of Colorado, Denver 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 7 inclusion and 5 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 23 Jan 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Jan 2020). 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?
Change in The Numerical Rating Scale Pain Score (time frame: Baseline and 48 hours). 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 23 Jan 2020.