Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02181205
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postdural Puncture Headache; Sphenopalatine Ganglion Block	Drug: bupivacaine; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Dec 31, 2016
• Anticipated Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: placebo sphenopalatine ganglion block performed with normal saline as the placebo	Drug: placebo
Active Comparator: bupivacaine sphenopalatine ganglion block performed with bupivacaine	Drug: bupivacaine

Outcome Measures

Primary Outcome Measures

1. verbal pain score [1 hour]

   a reduction in headache verbal pain score by 3

Secondary Outcome Measures

1. epidural blood patch [7 days]

   evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache

2. patient satisfaction [1 hour]

   patient satisfaction with headache pain relief at 1 hour post treatment

3. pain score [30 minutes]

   verbal pain score 30 minutes post study treatment

4. pain score [7 days]

   verbal pain score 7 days post study treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Peter H Pan, MD, MSEE, Wake Forest School of Medicine-Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02181205
• Other Study ID Numbers: 14-024
• First Posted: Jul 3, 2014
• Last Update Posted: Nov 8, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache; Headache; Bupivacaine

Study Results

No Results Posted as of Nov 8, 2017