Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02181205
• Other study ID #: 14-024
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2014
• Last updated: November 6, 2017
• Start date: November 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache
• Sphenopalatine Ganglion Block

Intervention

Drug:
• bupivacaine

• placebo

Locations

Country	Name	City	State
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	verbal pain score	a reduction in headache verbal pain score by 3	1 hour
Secondary	epidural blood patch	evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache	7 days
Secondary	patient satisfaction	patient satisfaction with headache pain relief at 1 hour post treatment	1 hour
Secondary	pain score	verbal pain score 30 minutes post study treatment	30 minutes
Secondary	pain score	verbal pain score 7 days post study treatment	7 days