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Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02181205
Enrollment
0
Registered
2014-07-03
Start date
2014-11-30
Completion date
2016-12-31
Last updated
2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache, Sphenopalatine Ganglion Block

Brief summary

The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.

Interventions

DRUGbupivacaine
DRUGplacebo

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists assigned class I-III * age \>/= 18 years * experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated \>3/10 pain score

Exclusion criteria

* allergy to study medications \<18 years of age pain score on presentation \</=3/10 for headache

Design outcomes

Primary

MeasureTime frameDescription
verbal pain score1 houra reduction in headache verbal pain score by 3

Secondary

MeasureTime frameDescription
epidural blood patch7 daysevaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache
patient satisfaction1 hourpatient satisfaction with headache pain relief at 1 hour post treatment
pain score30 minutesverbal pain score 30 minutes post study treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026