Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine ganglion block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Throughout the 24-hour observation period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional "General Ignacio Zaragoza," ISSSTE | Mexico City | Mexico City | 09360 | Mexico |
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).
Beginning at the time of article publication, with no end date.
Data and code will be publicly available with no access restrictions via GitHub.
Not provided
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
Not provided
Not provided
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).
Not provided
Not provided
This was a single-blind trial. Blinding of patients and treating clinicians was not feasible given the nature of the interventions. The outcome assessor collecting NRS pain scores was instructed to remain blinded to group allocation and was not involved in treatment delivery.
|
| Conservative management | Other | 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). |
|
| Rescue analgesia requirement | Proportion of patients requiring rescue analgesia (tramadol) at each time point. Between-group differences assessed using Fisher's exact test. | 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. | 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. | Throughout the 24-hour observation period |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |