Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Not Applicable

Withdrawn

• Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block
• Interventions: Drug: placebo; Drug: bupivacaine

• Registration Number: NCT02181205
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Study Start: 2014-11
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	sphenopalatine ganglion block performed with normal saline as the placebo
bupivacaine	bupivacaine	sphenopalatine ganglion block performed with bupivacaine

Primary Outcome Measures

Name	Time	Method
verbal pain score	1 hour	a reduction in headache verbal pain score by 3

Secondary Outcome Measures

Name	Time	Method
pain score	7 days	verbal pain score 7 days post study treatment
patient satisfaction	1 hour	patient satisfaction with headache pain relief at 1 hour post treatment
epidural blood patch	7 days	evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache

Trial Locations

Locations (1)

Novant Health Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States