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Completed

NCT Number: NCT07494383

Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional "General Ignacio Zaragoza," ISSSTE

Mexico City, 09360, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

  2. Rescue analgesia requirement

    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.

  3. Time to mobilisation

    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.

  4. Adverse events

    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.

Sponsors and collaborators

Lead sponsor

ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

Other Gov

Registry information

Official study title

Sphenopalatine Ganglion Block Versus Conservative Management for Post-Dural Puncture Headache Following Accidental Large-Bore Dural Puncture: A Pilot Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2026
Registry last updated
May 15, 2026

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.

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