Sphenopalatine Ganglion Block for Headache After Concussion

University of Michigan

Status and phase: Terminated; Phase 2

Conditions: Concussion; Headache

Treatments: Combination Product: Lidocaine in SphenoCath device; Combination Product: Saline Solution in SphenoCath device

Study type: Interventional

Funder types: Other

Identifiers

NCT04650282

HUM00185200

Details and patient eligibility

About

This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.

Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).

Enrollment: 2 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with a concussion and are greater than 14 days from the date of their injury.
• Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.

Exclusion criteria

• Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
• Frequent epistaxis (i.e. more than one nose bleed per month),
• Bleeding disorders
• History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
• Pregnant
• Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Lidocaine in SphenoCath device

Experimental group

Description:

One treatment will be given.

Treatment:

Combination Product: Lidocaine in SphenoCath device

Saline Solution in SphenoCath device

Placebo Comparator group

Description:

One treatment will be given.

Treatment:

Combination Product: Saline Solution in SphenoCath device