Sphenopalatine Ganglion Block for Post-Dural Puncture Headache: A Randomised Controlled Trial

  1. Gustavo Everardo-Salazar
  2. Phabel A. López-Delgado
  3. Mirna M. Delgado-Carlo
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Abstract

Background

Post-dural puncture headache (PDPH) affects up to 11.2% of patients after neuraxial anesthesia. The sphenopalatine ganglion block (SPGB) is a promising minimally invasive intervention, but high-quality randomised trial data are limited. We conducted a randomised controlled trial to evaluate the efficacy of SPGB compared to conservative management for PDPH.

Methods

Twenty-six patients with PDPH following accidental dural puncture with 17G Tuohy needles were randomised to conservative management (bed rest, hydration) or SPGB (bilateral intranasal 2% lidocaine). The sample size was calculated using a two-sided test for comparing two proportions, with α = 0.05 and 80% power, assuming a 60% difference in pain resolution between groups (80% vs 20%), yielding 12 patients per group; accounting for 10% attrition, 26 patients were enrolled. Pain intensity was measured using the Numeric Rating Scale (NRS, 0-10) at 30 minutes, 12 hours, and 24 hours. Secondary outcomes included rescue analgesia requirements, mobilization time, and adverse events.

Results

Recruitment, retention, and protocol adherence were 100%. At 30 minutes, all SPGB patients reported complete pain resolution (NRS=0) versus median NRS 3 (IQR 2) in controls (p<0.001). No SPGB patients required rescue analgesia or experienced adverse events. Conservative group patients had prolonged hospitalization (46%). Based on these findings, a sample size calculation for a future sham-controlled trial (90% power, α = 0.05) yields 120 participants (60/group).

Conclusions

SPGB provided rapid and complete pain resolution in all treated patients, with no adverse events and significantly earlier mobilization compared to conservative management. These findings support the conduct of a larger sham-controlled trial to confirm the efficacy of SPGB for PDPH.

Trial registration

ClinicalTrials.gov - NCT07494383 (retrospectively registered).

Highlights

  • RCT demonstrates that SPGB provides complete pain resolution in all 13 treated patients at 30 minutes.

  • 100% recruitment, retention, and protocol adherence achieved (n=26).

  • All SPGB patients reported complete pain resolution (NRS=0) at 30 minutes.

  • No adverse events with SPGB; 46% of controls required prolonged hospitalization.

  • A future sham-controlled trial would require 120 participants (60/group) for 90% power.

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    1. Version published to 10.64898/2026.05.06.26352338 on medRxiv