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no enrollment after covid pandemic
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| Name | Class |
|---|---|
| New Jersey Medical School | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural blood patch | Active Comparator | 20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access. |
|
| Sphenopalatine Ganglion Block | Experimental | Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Blood Patch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Grubb, DDS, MD | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Pain Center | New Brunswick | New Jersey | 08901 | United States | ||
| RWJUH/Barnabus |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Blood Patch Group | 20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access. 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. |
| FG001 | Sphenopalatine Ganglion Block Group | Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Blood Patch | 20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | patients having known dural puncture after epidural access for analgesia | Posted | Number | headache with VAS >8/10 | Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural Blood Patch Group | 20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| william grubb md | RWJMS/Rutgers Health | 732 235 7827 | grubbwr@rwjms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2021 | Oct 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2021 | Oct 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017217 | Blood Patch, Epidural |
| D059387 | Sphenopalatine Ganglion Block |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
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|
| Sphenopalatine Ganglion Block | Drug | 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. |
|
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| BG001 | Sphenopalatine Ganglion Block | Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sphenopalatine Ganglion Block Group | Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion 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. |
|
|
| 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). | patients having a known dural puncture associated with epidural placement for analgesia | Posted | Count of Participants | Participants | 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). | patients with headache after known dural puncture after epidural access for analgesia | Posted | Count of Participants | Participants | At 60 minutes following either therapy. |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sphenopalatine Ganglion Block Group | Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009422 | Nervous System Diseases |
| D007267 |
| Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |