Postdural Puncture HeadacheSPGBNCT04515901
Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches
A study testing 2% lidocaine in people with Postdural Puncture Headache, run by McMaster University at 1 site in Canada.
Trial summary
Postdural puncture headache (PDPH) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. Presently, the conservative treatment options for PDPH have limited effectiveness and the gold standard treatment for PDPH, an epidural blood… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- 2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to 11 Nov 2022
- 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
- Age 18-45
- Confirmed PDPH as per ICHD-3 diagnostic criteria
Who cannot join
- American Society of Anesthesiologists (ASA) class 4 and above
- History of chronic headaches or migraines requiring prescription medication
- Known nasal septal deformity or abnormality
- Known allergy to amide anesthetics
- Intrathecal catheters
- Patients who received EBP on the initial presentation with PDPH who declined a trial of conservative management
- Postpartum complication delaying maternal discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention Sphenopalatine Ganglion Blocks (SPGBs) Versus Standard Conservative Management of Post Dural Puncture Headache in Obstetric Patients - A Randomized Feasibility Study
Postdural puncture headache (PDPH) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. Presently, the conservative treatment options for PDPH have limited effectiveness and the gold standard treatment for PDPH, an epidural blood patch, is an invasive intervention with the potential for serious complications. There is a growing number of case reports and retrospective studies that suggest a sphenopalatine ganglion block (SPGB) with local anesthetic may offer an effective, safe, and easy-to-administer treatment option for PDPH in postpartum patients. We aim to conduct a feasibility study to assess whether a randomized controlled trial is feasible comparing whether early intervention SPGB with the option for repeat, patient self-administered SPGBs versus current standard conservative management can reduce the severity and duration of PDPH pain and improve patient functional status.
- Conditions
- Postdural Puncture Headache
- Being tested
- 2% lidocaine, 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.
2% lidocaineDrug
Viscous lidocaine
PlaceboOther
Methylcellulose and cherry flavouring
| Study group | Role | What they receive |
|---|---|---|
| SPGB | Experimental | Via a soft tip 20-gauge long IV catheter attached to a 3 mL syringe will be filled with 2 mL of 2% viscous lidocaine. The 2% viscous lidocaine will be administered according to the method of Barre. Receives: Drug: 2% lidocaine |
| Placebo | Placebo comparator | It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number of consented patients over number of number of eligible patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Dec 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Why it stopped: Unable to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515901
- Sponsor's protocol ID
- 7978
- Acronym
- SPGB
- Status last verified
- Dec 2022
- First submitted
- 11 Aug 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
PubMed 15814755Barre F. Cocaine as an abortive agent in cluster headache. Headache. 1982 Mar;22(2):69-73. doi: 10.1111/j.1526-4610.1982.hed2202069.x. No abstract available.
PubMed 7085264Channabasappa SM, Manjunath S, Bommalingappa B, Ramachandra S, Banuprakash S. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache following spinal anesthesia. Saudi J Anaesth. 2017 Jul-Sep;11(3):362-363. doi: 10.4103/sja.SJA_59_17. No abstract available.
PubMed 28757848Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.
PubMed 12734154
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention Sphenopalatine Ganglion Blocks (SPGBs) Versus Standard Conservative Management of Post Dural Puncture Headache in Obstetric Patients - A Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT04515901
- Acronym / sponsor ID
- SPGB / 7978
- Conditions
- Postdural Puncture Headache
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 17 Aug 2020 (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.
Postdural puncture headache (PDPH) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. Presently, the conservative treatment options for PDPH have limited effectiveness and the gold standard treatment for PDPH, an epidural blood patch, is an invasive intervention with the potential for serious complications. There is a growing number of case reports and retrospective studies that suggest a sphenopalatine ganglion block (SPGB) with local anesthetic may offer an effective, safe, and easy-to-administer treatment option for PDPH in postpartum patients. We aim to conduct a feasibility study to assess whether a randomized controlled trial is feasible comparing whether early intervention SPGB with the option for repeat, patient self-administered SPGBs versus current standard conservative management can reduce the severity and duration of PDPH pain and improve patient functional status.
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 |
|---|---|---|
| SPGB | Experimental | Drug: 2% lidocaineVia a soft tip 20-gauge long IV catheter attached to a 3 mL syringe will be filled with 2 mL of 2% viscous lidocaine. The 2% viscous lidocaine will be administered according to the method of Barre. |
| Placebo | Placebo comparator | Other: PlaceboIt will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-45
- Confirmed PDPH as per ICHD-3 diagnostic criteria
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) class 4 and above
- History of chronic headaches or migraines requiring prescription medication
- Known nasal septal deformity or abnormality
- Known allergy to amide anesthetics
- Intrathecal catheters
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 |
|---|---|---|
| 2% lidocaineViscous lidocaine | Drug | SPGB |
| PlaceboMethylcellulose and cherry flavouring | Other | Placebo |
Primary outcome
Enrollment rate
Time frame: 6 months
Number of consented patients over number of number of eligible patients
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 7 Jul 2026.
- Background: PubMed 15814755Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
- Background: PubMed 7085264Barre F. Cocaine as an abortive agent in cluster headache. Headache. 1982 Mar;22(2):69-73. doi: 10.1111/j.1526-4610.1982.hed2202069.x. No abstract available.
- Background: PubMed 28757848Channabasappa SM, Manjunath S, Bommalingappa B, Ramachandra S, Banuprakash S. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache following spinal anesthesia. Saudi J Anaesth. 2017 Jul-Sep;11(3):362-363. doi: 10.4103/sja.SJA_59_17. No abstract available.
- Background: PubMed 12734154Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% lidocaine in people with Postdural Puncture Headache, run by McMaster University at 1 site in Canada.
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 7 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 7 Jul 2026. 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 Canada. 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.
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?
Enrollment rate (time frame: 6 months). 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 NCT04515901, which also lists 4 linked publications.
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 7 Jul 2026.