Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

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.

Study Overview

• Status: Completed
• Conditions: Headache; Post-Dural Puncture Headache
• Intervention / Treatment: Procedure: Sphenopalatine ganglion block; Other: Conservative management

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 09360
      • Hospital Regional "General Ignacio Zaragoza," ISSSTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPGB; 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.	Procedure: Sphenopalatine 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.
Active Comparator: CON; 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).	Other: Conservative management; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Lidocaine; Pilot study; Post-dural puncture headache; Regional anaesthesia; PDPH; Sphenopalatine ganglion block; SPGB; Neuraxial anaesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Post-Dural Puncture Headache; Therapeutics; Surgical Procedures, Operative; Anesthesia and Analgesia; Neurosurgical Procedures; Anesthesia, Conduction; Anesthesia; Denervation; Autonomic Nerve Block; Nerve Block; Conservative Treatment; Sphenopalatine Ganglion Block
• Other Study ID Numbers: ISSSTE RPI #408-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Beginning at the time of article publication, with no end date.
• IPD Sharing Access Criteria: Data and code will be publicly available with no access restrictions via GitHub.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No