Postdural Puncture HeadacheNCT02181205
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
A study testing bupivacaine in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postdural Puncture Headache, Sphenopalatine Ganglion Block
- What is being tested?
- bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 31 Dec 2016
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists assigned class I-III
- age >/= 18 years
- experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score
Who cannot join
- allergy to study medications <18 years of age pain score on presentation </=3/10 for headache
Trial locations and contacts
1 site in 1 country.
United States1 site
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.
- Being tested
- bupivacaine, 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.
bupivacaineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Experimental | sphenopalatine ganglion block performed with normal saline as the placebo Receives: Drug: placebo |
| bupivacaine | Active comparator | sphenopalatine ganglion block performed with bupivacaine Receives: Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
verbal pain score
a reduction in headache verbal pain score by 3
Measured: 1 hour
Secondary outcomes (4)
epidural blood patch
evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache
Measured: 7 days
patient satisfaction
patient satisfaction with headache pain relief at 1 hour post treatment
Measured: 1 hour
pain score
verbal pain score 30 minutes post study treatment
Measured: 30 minutes
pain score
verbal pain score 7 days post study treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startNov 2014
- Primary completion31 Dec 2016 (estimated)
- Study completion31 Dec 2016 (estimated)
Why it stopped: no eligible participant , technical difficulty, feasiblity
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 Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H Pan, MD, MSEE, Principal investigator, Wake Forest School of Medicine-Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181205
- Sponsor's protocol ID
- 14-024
- Status last verified
- Feb 2017
- First submitted
- 1 Jul 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02181205
- Acronym / sponsor ID
- 14-024
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no eligible participant , technical difficulty, feasiblity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 31 Dec 2016 (estimated)
- Study completion
- 31 Dec 2016 (estimated)
- First posted
- 3 Jul 2014 (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.
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Experimental | Drug: placebosphenopalatine ganglion block performed with normal saline as the placebo |
| bupivacaine | Active comparator | Drug: bupivacainesphenopalatine ganglion block performed with bupivacaine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists assigned class I-III
- age >/= 18 years
- experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score
Key exclusion criteria (1 listed)
- allergy to study medications <18 years of age pain score on presentation </=3/10 for headache
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 |
|---|---|---|
| bupivacaine | Drug | bupivacaine |
| placebo | Drug | placebo |
Primary outcome
verbal pain score
Time frame: 1 hour
a reduction in headache verbal pain score by 3
4 secondary outcomes
epidural blood patch
Time frame: 7 days
patient satisfaction
Time frame: 1 hour
pain score
Time frame: 30 minutes
pain score
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
Related trials for Postdural Puncture Headache
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
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.
Peter H Pan, MD, MSEE principal investigator
Wake Forest School of Medicine-Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by Wake Forest University Health Sciences 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 1 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: withdrawn, as of the sponsor's last update on 8 Nov 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. 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 withdrawn before enrolling participants, so there are no results.
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?
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 8 Nov 2017.