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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03112720
Other study ID # Pro20140000026
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2016
Est. completion date September 2020

Study information

Verified date June 2023
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 92 Years
Eligibility Inclusion Criteria: - Males and females ages 13-92 - Subjects have medical diagnosis of PDPH and require treatment - Subjects who signed consent/assent Exclusion Criteria: - <13 years of age - Pregnancy - Subjects with heart failure - Subjects already being treated with lidocaine patch or other vehicle for chronic pain - Non-english speaking subjects - Subjects with platelets <100,000 - Subjects that are septic - Subjects with an allergy to lidocaine - Subjects with known nasal polyps - Subjects with recent neurological event - Subjects on anticoagulant therapy - Subjects that received prior therapy with SPG block or EBP

Study Design


Intervention

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.

Locations

Country Name City State
United States New Jersey Pain Center New Brunswick New Jersey
United States RWJUH/Barnabus New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey New Jersey Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy Outcome measure will entail recording patient self-reported pain scores to quantify the level of headache pain using the Visual analog scale, meaning 0 - No pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-10 - Severe Pain, by way of in person assessment by pain questionnaire just prior to initiation of either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Primary Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy. Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 30 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). At 30 minutes following either therapy.
Primary Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy. Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 60 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). At 60 minutes following either therapy.
See also
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Completed NCT03652714 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache Phase 3
Completed NCT02859233 - Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache N/A
Withdrawn NCT02181205 - Sphenopalatine Ganglion Block for Post-Dural Puncture Headache N/A
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Completed NCT06394024 - Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
Withdrawn NCT03966547 - Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714 N/A
Completed NCT06380764 - Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache N/A
Terminated NCT02365909 - Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) Early Phase 1
Completed NCT04910477 - Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache Phase 3
Completed NCT05969119 - Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache Phase 4
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Not yet recruiting NCT04709029 - Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache N/A
Withdrawn NCT02517931 - Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department N/A
Recruiting NCT06271486 - Pregabalin in Treatment of Postdural Puncture Headache Phase 3
Completed NCT00465166 - Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural N/A
Not yet recruiting NCT05212194 - The Relationship Between Post Dural Puncture Headache and Joint Laxity N/A
Completed NCT05777694 - Postdural Punction Headache After Ceserian Section N/A
Withdrawn NCT04515901 - Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches N/A
Completed NCT04892290 - Sphenopalatine Ganglion Block for Postdural Puncture Headache