Postdural Puncture Headache
Conditions
Brief 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.
Interventions
DEVICEEpidural 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.
DRUGSphenopalatine 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.
Sponsors
New Jersey Medical School
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 92 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy | Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). | 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). |
| Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy. | 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). |
| Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | Sphenopalatine Ganglion Block | Total | Epidural Blood Patch |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 8 Participants | 5 Participants |
| Age, Continuous | 24.3 years | 29.25 years | 30.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 8 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
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).
Time frame: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Population: patients having known dural puncture after epidural access for analgesia
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epidural Blood Patch Group | Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy | 1 headache with VAS >8/10 |
| Sphenopalatine Ganglion Block Group | Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy | 1 headache with VAS >8/10 |
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).
Time frame: At 30 minutes following either therapy.
Population: patients having a known dural puncture associated with epidural placement for analgesia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Blood Patch Group | Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy. | 1 Participants |
| Sphenopalatine Ganglion Block Group | Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy. | 1 Participants |
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).
Time frame: At 60 minutes following either therapy.
Population: patients with headache after known dural puncture after epidural access for analgesia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Blood Patch Group | Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy. | 1 Participants |
| Sphenopalatine Ganglion Block Group | Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy. | 0 Participants |
p-value: <0.01Chi-squared