Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

Postdural Puncture Headache Clinical Trial

Official title:

Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache in the Emergency Department: A Prospective, Randomized, Double-Blind Placebo Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02517931
• Other study ID #: 204502
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 23, 2019

Study information

• Verified date: September 2019
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Description:

Postdural puncture headaches (PDPH) are a common consequence of diagnostic lumbar puncture. The gold standard treatment for a PDPH is currently an autologous epidural blood patch (AEBP), which involves placing a needle into the epidural space of the spine and then injecting 20 ml of the patients own blood through the needle and into the epidural space to form a clot over the tear in the tissue layer that causes the headache. This is an invasive procedure that carries risks of pain, bleeding, infection, and in rare cases, neurological complications. We want to test the efficacy of using a less invasive procedure, called a sphenopalatine ganglion 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. We hope that the SPGB will reduce the number of PDPH patients that require an AEBP.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active postdural puncture headache within 7 days after diagnostic lumbar puncture

• Age = 18 years.

• American Society of Anesthesiologists (ASA) physical status = 3

Exclusion Criteria:

• Known coagulopathy

• Known nasal septal deviation or abnormalities

• Medical conditions contraindicated to lidocaine or bupivacaine

Related Conditions & MeSH terms

• Emergencies
• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Procedure:
• Sphenopalatine Ganglion Block
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (Rhinall?) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1mL of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
• Placebo
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (Rhinall?) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level with Verbal Rating Scale	Patients will be asked to self rate their pain with 0 as no pain at all up to 10 being the worst pain imaginable.	5 days