Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

• Sponsor: University of Arkansas (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02365909
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

Condition or Disease	Intervention/Treatment	Phase
Postdural Puncture Headache	Drug: 0.5% bupivacaine; Drug: normal saline	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
• Actual Study Start Date: Jun 29, 2015
• Actual Primary Completion Date: Aug 30, 2016
• Actual Study Completion Date: Aug 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acitve This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®	Drug: 0.5% bupivacaine; This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Placebo Comparator: Placebo This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®	Drug: normal saline; This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Outcome Measures

Primary Outcome Measures

1. Headache verbal pain score [1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia

• Age ≥ 18 years.

• ASA physical status ≤ 3

Exclusion Criteria

• Known coagulopathy

• Known nasal septal deviation or abnormalities

• Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02365909
• Other Study ID Numbers: 203684
• First Posted: Feb 19, 2015
• Last Update Posted: Sep 18, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Post-Dural Puncture Headache; Headache; Bupivacaine

Study Results

No Results Posted as of Sep 18, 2017