Hospital Regional "General Ignacio Zaragoza," ISSSTE
Mexico City, 09360, Mexico
NCT Number: NCT07494383
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Mexico City, 09360, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Elimination Criteria:
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).
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.
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.
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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
Other Gov
Sphenopalatine Ganglion Block Versus Conservative Management for Post-Dural Puncture Headache Following Accidental Large-Bore Dural Puncture: A Pilot Randomised Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00370604
Agnosia, Brain Diseases
Vancouver, British Columbia, Canada
View Trial DetailsNCT05888324
Blood Patch, Brain Diseases
Paris, Île-de-France Region, France
View Trial DetailsNCT06992063
Brain Diseases, Central Nervous System Diseases
Düzce, Turkey (Türkiye)
View Trial DetailsNCT06957899
Brain Diseases, Central Nervous System Diseases
Meram, Konya, Turkey (Türkiye)
View Trial Details