NCT03112720

Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 13 Years – 92 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

Detailed description

The sphenopalatine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalatine nerve block will help the patient with the headache.

Conditions

• Postdural Puncture Headache

Interventions

Type	Name	Description
DEVICE	Epidural Blood Patch	A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.
DRUG	Sphenopalatine Ganglion Block	The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2017-04-13
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study