A Phase 3 interventional study of Epidural Blood Patch and Sphenopalatine Ganglion Block in Postdural Puncture Headache, sponsored by Rutgers, The State University of New Jersey. Terminated at 2 sites in United States. Open to participants aged 13 Years to 92 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Rutgers, The State University of New Jersey · Phase 3, Interventional, and Treatment
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
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.
125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 82 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.
Device: Epidural Blood Patch
Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion
Drug: Sphenopalatine Ganglion Block
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.
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.
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).
Time frame: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
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).
Time frame: At 30 minutes following either therapy.
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).
Time frame: At 60 minutes following either therapy.
| Milestone | Epidural Blood Patch Group | Sphenopalatine Ganglion Block Group |
|---|---|---|
| Started | 5 | 3 |
| Completed | 5 | 3 |
| Not completed | 0 | 0 |
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).
| headache with VAS >8/10 | Epidural Blood Patch Group | Sphenopalatine Ganglion Block Group |
|---|---|---|
| Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy | 1 | 1 |
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).
| Participants | Epidural Blood Patch Group | Sphenopalatine Ganglion Block Group |
|---|---|---|
| Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy. | 1 | 1 |
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).
| Participants | Epidural Blood Patch Group | Sphenopalatine Ganglion Block Group |
|---|---|---|
| Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy. | 1 | 0 |
Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epidural Blood Patch Group | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Sphenopalatine Ganglion Block Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Epidural Blood Patch | Sphenopalatine Ganglion Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 3 | 8 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Epidural Blood Patch | Sphenopalatine Ganglion Block | Total |
|---|---|---|---|
| Mean | 30.4 (27 to 33) | 24.3 (23 to 34) | 29.25 (23 to 34) |
| Sex: Female, Male(Participants) | Epidural Blood Patch | Sphenopalatine Ganglion Block | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Epidural Blood Patch | Sphenopalatine Ganglion Block | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Epidural Blood Patch | Sphenopalatine Ganglion Block | Total |
|---|---|---|---|
| United States | 5 | 3 | 8 |
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Rutgers, The State University of New Jersey