Post-Dural Puncture Headache, Headache
Conditions
Keywords
Post-dural puncture headache, Sphenopalatine ganglion block, PDPH, SPGB, Pilot study, Randomised controlled trial, Regional anaesthesia, Neuraxial anaesthesia, Lidocaine
Brief 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 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.
Interventions
PROCEDURESphenopalatine ganglion block
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.
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).
Sponsors
ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: recruitment rate | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity by Numerical Rating Scale (NRS) | Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention | 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. |
| Rescue analgesia requirement | At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention | Proportion of patients requiring rescue analgesia (tramadol) at each time point. Between-group differences assessed using Fisher's exact test. |
| Time to mobilisation | At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention | 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. |
| Adverse events | Throughout the 24-hour observation period | Incidence of any adverse events in either group, including anosmia, epistaxis, prolonged hospitalisation, or any other clinically significant event. Reported descriptively. |
Countries
Mexico
Outcome results
None listed