Post-Dural Puncture HeadacheNCT07494383
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
A study testing Sphenopalatine ganglion block and Conservative management in people with Post-Dural Puncture Headache and Headache, run by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" at 1 site in Mexico.
Trial summary
This pilot randomised controlled trial compared sphenopalatine ganglion block (SPGB) using intranasal 2% lidocaine versus conservative management (bed rest and aggressive hydration) in patients who developed post-dural puncture headache (PDPH) following accidental dural puncture with 17G Tuohy needles during epidural… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post-Dural Puncture Headache, Headache
- What is being tested?
- Sphenopalatine ganglion block and Conservative management
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteMexico
- Study dates
- 29 May 2024to 28 Jun 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- ASA physical status I or II
- Developed post-dural puncture headache following accidental dural puncture with a 17G Tuohy needle during an epidural procedure
- Enrolled within 24 hours of dural puncture
- PDPH diagnosed clinically as headache with postural characteristics (worsening upright, relief supine), consistent with ICHD criteria
- Willing to provide written informed consent
Who cannot join
- History of migraine or chronic headache
- Received prior intervention for PDPH before enrolment
- Chronic use of anticonvulsants, gabapentinoids, or weak opioids
- Elimination Criteria:
- Patient withdrawal of consent at any point during the study
- Development of side effects requiring further interventional management
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional "General Ignacio Zaragoza," ISSSTE
Mexico City, Mexico City, 09360
About this study
Official title: Sphenopalatine Ganglion Block Versus Conservative Management for Post-Dural Puncture Headache Following Accidental Large-Bore Dural Puncture: A Pilot Randomised Controlled Trial
This pilot randomised controlled trial compared sphenopalatine ganglion block (SPGB) using intranasal 2% lidocaine versus conservative management (bed rest and aggressive hydration) in patients who developed post-dural puncture headache (PDPH) following accidental dural puncture with 17G Tuohy needles during epidural procedures. The primary outcomes were feasibility metrics (recruitment, retention, and protocol adherence). Secondary outcomes included pain intensity measured by the Numerical Rating Scale (NRS 0-10) at 30 minutes, 12 hours, and 24 hours post-intervention; rescue analgesia requirements; mobilisation time; and adverse events.
Read the detailed description
Post-dural puncture headache is a significant complication of neuraxial anaesthesia, with substantially higher incidence and severity following accidental large-bore needle punctures. Conservative management (bed rest, hydration) lacks robust efficacy evidence, and epidural blood patch implementation is often delayed. The sphenopalatine ganglion block has emerged as a promising minimally invasive alternative, but high-quality randomised trial data are limited.
This single-centre, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Twenty-six patients (ASA I-II, age 18-55 years) who developed PDPH following accidental dural puncture with 17G Tuohy needles during epidural procedures were randomised using a computer-generated sequence to conservative management (n=13) or SPGB (n=13).
Conservative management comprised strict bed rest (supine then prone positioning), bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline 125 mL/hr plus a minimum of 3L oral fluids/24h). SPGB involved bilateral insertion of cotton-tipped applicators saturated with 2 mL of 2% lidocaine at 45° to the hard palate, advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes. Interventions were initiated immediately post-randomisation. The outcome assessor was blinded to group allocation.
The trial was prospectively approved by the institutional ethics and research committee (Reference A2024-1014) and registered with the ISSSTE institutional research registry (RPI #408-2024) prior to enrolment of the first participant. Registration on ClinicalTrials.gov was not completed at the time of study initiation due to institutional policy restrictions in place at that time. This record documents the study retrospectively; the prospective institutional approval and registration are documented under the IRB approval number above.
- Conditions
- Post-Dural Puncture Headache, Headache
- Being tested
- Sphenopalatine ganglion block, Conservative management
- Keywords
- Post-dural puncture headache, Sphenopalatine ganglion block, PDPH, SPGB, Pilot study, Randomised controlled trial, Regional anaesthesia, Neuraxial anaesthesia, Lidocaine
- Medical subject headings
- Post-Dural Puncture Headache, 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
Bilateral transnasal sphenopalatine ganglion block using cotton-tipped applicators saturated with 2 mL of 2% lidocaine (total 4 mL), applied for 15-20 minutes. Patient positioned supine with slight cervical extension during the procedure.
Conservative managementOther
Strict bed rest (supine then prone positioning) with bathroom privileges at bedside only, combined with aggressive intravenous and oral hydration (IV 0.9% saline at 125 mL/hr plus a minimum of 3L oral fluids per 24 hours).
| Study group | Role | What they receive |
|---|---|---|
| SPGB | Experimental | Participants received bilateral sphenopalatine ganglion block using cotton-tipped applicators saturated with 2 mL of 2% lidocaine, inserted at 45° to the hard palate and advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes before removal. Receives: Procedure: Sphenopalatine ganglion block |
| CON | Active comparator | Participants received conservative management comprising strict bed rest (supine then prone positioning) with bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline at 125 mL/hr plus a minimum of 3L oral fluids per 24 hours). Receives: Other: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: recruitment rate
Proportion of eligible patients who were successfully recruited and randomised to meet the pre-specified pilot sample size target of 26 participants.
Measured: At study completion (enrolment period)
Feasibility: retention rate
Proportion of randomised participants who completed all follow-up assessments through 24 hours, expressed as a percentage with 95% confidence interval.
Measured: At 24 hours post-intervention (T3)
Feasibility: protocol adherence
Proportion of participants in each group who received their allocated intervention in full accordance with the study protocol, expressed as a percentage with 95% confidence interval.
Measured: Throughout the 24-hour observation period
Secondary outcomes (4)
Pain intensity by Numerical Rating Scale (NRS)
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). Between-group differences analysed using Mann-Whitney U tests. Effect sizes expressed as rank-biserial correlation coefficients (r) with 95% confidence intervals.
Measured: Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Rescue analgesia requirement
Proportion of patients requiring rescue analgesia (tramadol) at each time point. Between-group differences assessed using Fisher's exact test.
Measured: At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Time to mobilisation
Proportion of patients remaining in bed at each time point, reflecting time to free ambulation without PDPH symptoms. Between-group differences assessed using Fisher's exact test.
Measured: At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Adverse events
Incidence of any adverse events in either group, including anosmia, epistaxis, prolonged hospitalisation, or any other clinically significant event. Reported descriptively.
Measured: Throughout the 24-hour observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start29 May 2024
- Primary completion24 Jun 2024
- Study completion28 Jun 2024
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
- Model description
- Two-arm parallel-group pilot RCT. Participants were randomised equally (n=13 per group) to receive sphenopalatine ganglion block with 2% lidocaine or conservative management (bed rest and aggressive hydration).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mirna Magali Delgado Carlo, ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494383
- Sponsor's protocol ID
- ISSSTE RPI #408-2024
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block Versus Conservative Management for Post-Dural Puncture Headache Following Accidental Large-Bore Dural Puncture: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07494383
- Acronym / sponsor ID
- ISSSTE RPI #408-2024
- Conditions
- Post-Dural Puncture Headache, Headache
- Keywords
- Post-dural puncture headache, Sphenopalatine ganglion block, PDPH, SPGB, Pilot study, Randomised controlled trial, Regional anaesthesia, Neuraxial anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"Other government
- Study start
- 29 May 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 27 Mar 2026 (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.
This pilot randomised controlled trial compared sphenopalatine ganglion block (SPGB) using intranasal 2% lidocaine versus conservative management (bed rest and aggressive hydration) in patients who developed post-dural puncture headache (PDPH) following accidental dural puncture with 17G Tuohy needles during epidural procedures. The primary outcomes were feasibility metrics (recruitment, retention, and protocol adherence). Secondary outcomes included pain intensity measured by the Numerical Rating Scale (NRS 0-10) at 30 minutes, 12 hours, and 24 hours post-intervention; rescue analgesia requirements; mobilisation time; and adverse events.
Detailed description
Post-dural puncture headache is a significant complication of neuraxial anaesthesia, with substantially higher incidence and severity following accidental large-bore needle punctures. Conservative management (bed rest, hydration) lacks robust efficacy evidence, and epidural blood patch implementation is often delayed. The sphenopalatine ganglion block has emerged as a promising minimally invasive alternative, but high-quality randomised trial data are limited.
This single-centre, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Twenty-six patients (ASA I-II, age 18-55 years) who developed PDPH following accidental dural puncture with 17G Tuohy needles during epidural procedures were randomised using a computer-generated sequence to conservative management (n=13) or SPGB (n=13).
Conservative management comprised strict bed rest (supine then prone positioning), bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline 125 mL/hr plus a minimum of 3L oral fluids/24h). SPGB involved bilateral insertion of cotton-tipped applicators saturated with 2 mL of 2% lidocaine at 45° to the hard palate, advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes. Interventions were initiated immediately post-randomisation. The outcome assessor was blinded to group allocation.
The trial was prospectively approved by the institutional ethics and research committee (Reference A2024-1014) and registered with the ISSSTE institutional research registry (RPI #408-2024) prior to enrolment of the first participant. Registration on ClinicalTrials.gov was not completed at the time of study initiation due to institutional policy restrictions in place at that time. This record documents the study retrospectively; the prospective institutional approval and registration are documented under the IRB approval number above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group pilot RCT. Participants were randomised equally (n=13 per group) to receive sphenopalatine ganglion block with 2% lidocaine or conservative management (bed rest and aggressive hydration).
| Arm | Type | Receives |
|---|---|---|
| SPGB | Experimental | Procedure: Sphenopalatine ganglion blockParticipants received bilateral sphenopalatine ganglion block using cotton-tipped applicators saturated with 2 mL of 2% lidocaine, inserted at 45° to the hard palate and advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes before removal. |
| CON | Active comparator | Other: Conservative managementParticipants received conservative management comprising strict bed rest (supine then prone positioning) with bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline at 125 mL/hr plus a minimum of 3L oral fluids per 24 hours). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-55 years
- ASA physical status I or II
- Developed post-dural puncture headache following accidental dural puncture with a 17G Tuohy needle during an epidural procedure
- Enrolled within 24 hours of dural puncture
- PDPH diagnosed clinically as headache with postural characteristics (worsening upright, relief supine), consistent with ICHD criteria
Key exclusion criteria (6 listed)
- History of migraine or chronic headache
- Received prior intervention for PDPH before enrolment
- Chronic use of anticonvulsants, gabapentinoids, or weak opioids
- Patient withdrawal of consent at any point during the study
- Development of side effects requiring further interventional management
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 blockBilateral transnasal sphenopalatine ganglion block using cotton-tipped applicators saturated with 2 mL of 2% lidocaine (total 4 mL), applied for 15-20 minutes. Patient positioned supine with slight cervical extension during the procedure. | Procedure or surgery | SPGB |
| Conservative managementStrict bed rest (supine then prone positioning) with bathroom privileges at bedside only, combined with aggressive intravenous and oral hydration (IV 0.9% saline at 125 mL/hr plus a minimum of 3L oral fluids per 24 hours). | Other | CON |
Primary outcome
Feasibility: recruitment rate
Time frame: At study completion (enrolment period)
Proportion of eligible patients who were successfully recruited and randomised to meet the pre-specified pilot sample size target of 26 participants.
Feasibility: retention rate
Time frame: At 24 hours post-intervention (T3)
Proportion of randomised participants who completed all follow-up assessments through 24 hours, expressed as a percentage with 95% confidence interval.
Feasibility: protocol adherence
Time frame: Throughout the 24-hour observation period
Proportion of participants in each group who received their allocated intervention in full accordance with the study protocol, expressed as a percentage with 95% confidence interval.
4 secondary outcomes
Pain intensity by Numerical Rating Scale (NRS)
Time frame: Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Rescue analgesia requirement
Time frame: At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Time to mobilisation
Time frame: At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Adverse events
Time frame: Throughout the 24-hour observation period
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 15 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).
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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 Sphenopalatine ganglion block and Conservative management in people with Post-Dural Puncture Headache and Headache, run by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" at 1 site in Mexico.
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 6 inclusion and 6 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 15 May 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 Mexico. 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 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?
Feasibility: recruitment rate (time frame: At study completion (enrolment period)). The study lists 3 primary outcomes in all. 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 15 May 2026.