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Clinical Trials/NCT02181205
NCT02181205
Withdrawn
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 countryNovember 2014

Overview

Phase
Not Applicable
Intervention
placebo
Conditions
Postdural Puncture Headache
Sponsor
Wake Forest University Health Sciences
Locations
1
Primary Endpoint
verbal pain score
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
December 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

placebo

sphenopalatine ganglion block performed with normal saline as the placebo

Intervention: placebo

bupivacaine

sphenopalatine ganglion block performed with bupivacaine

Intervention: bupivacaine

Outcomes

Primary Outcomes

verbal pain score

Time Frame: 1 hour

a reduction in headache verbal pain score by 3

Secondary Outcomes

  • pain score(7 days)
  • patient satisfaction(1 hour)
  • epidural blood patch(7 days)

Study Sites (1)

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