Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

NCT07494383 | Completed

• 1 other identifier: ISSSTE RPI #408-2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache; Headache

Keywords

Post-dural puncture headache; Sphenopalatine ganglion block; PDPH; SPGB; Pilot study; Randomised controlled trial; Regional anaesthesia; Neuraxial anaesthesia; Lidocaine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pain intensity by Numerical Rating Scale (NRS)

  Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention

• Rescue analgesia requirement

  At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention

• Time to mobilisation

  At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention

• Adverse events

  Throughout the 24-hour observation period

Study Arms (2)

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.

Procedure: Sphenopalatine ganglion block

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).

Other: Conservative management

Interventions

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.

SPGB

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).

CON

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional "General Ignacio Zaragoza," ISSSTE

Mexico City, Mexico City, 09360, Mexico

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache

Interventions

Sphenopalatine Ganglion Block; Conservative Treatment

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head and Coordinator of Anesthesiology Graduate Program, Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 29, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 28, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Beginning at the time of article publication, with no end date.
• Access Criteria: Data and code will be publicly available with no access restrictions via GitHub.

Locations

ME (1)