Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05734625
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-02-09
Brief Title:
Efficacy of Nerve Blocks for Episodic Migraine
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how well blocking two to ten of the scalp nerves that give feeling to the scalp and are painful during migraine headaches with bupivacaine anesthetic numbing medication and low dose methylprednisolone cortisone-like medicine or steroid work for treating and preventing migraines Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine
Detailed Description:
Hypothesis Multiple peripheral nerve blocks provide more complete acute headache relief and better headache prophylaxis in episodic migraine than greater occipital nerve blocks alone
Aims purpose or objectives
Compare whether anesthetizing multiple peripheral nerves of the scalp also known as multiple peripheral nerve block MPNB provides more acute headache pain relief than greater occipital nerve block GONB alone
Compare whether MPNB provides better headache prophylaxis than GONB alone measured monthly for three months
Determine whether there are fewer missed workschoollife activity days measured monthly for three months following nerve block for patients who receive MPNB compared to patients who receive GONB
Compare whether there are fewer Emergency RoomClinic visits for headache measured monthly for three months follow up for patients who receive MPNB compared to patients who receive GONB
Background
Peripheral nerve blocks PNBs have been studied in randomized trials and have proven beneficial and safe to varying degrees in the treatment of episodic migraine Most of these studies have evaluated GONBs two have looked at the combination of GONB and supraorbital nerve block SONB No study to date measuring pain relief in acute migraine and prophylaxis reported scalp anesthesia thus making conclusions about effect size of an actual nerve block on acute headache and prophylaxis or conclusions about optimal method medication dosages and frequency of blocks difficult
The PI has observed in his experience over 17 years administering many thousands of peripheral nerve blocks at MCR that essentially all patients get complete acute headache relief and most get durable prophylaxis for months if nerve blocks are administered in the distribution of a patients presenting headache and anesthesia is confirmed and documented in all nerves in the scalp distribution of the headache as many as 12 PNBs per patient to include bilateral greater occipital lesser occipital auriculotemporal supraorbital supratrochlear nerves and infraorbital nerves
In this study we will be randomizing patients to receive either GONBs alone or MPNBs to include all 10 scalp nerves and excluding patients with facial pain in the infraorbital nerve distribution during migraines
Study Design and Methods
Methods
Subjects with EMR documented episodic migraine headaches defined as 14 or less headache days per month frequency of which can be assessed at the time of initial discussion with the study coordinator will be recruited from our local patient population Study coordinators will then schedule a screening phone visit to explain the study and validate inclusionexclusion criteria and obtain written consent either digitally in person or eConsent and enroll the subject in the study
The research coordinator will then provide each subject with an initial questionnaire to obtain baseline data including episodic migraine headache diagnosis history of secondary headache causes location of their usual headache where in the head it starts and the progression frequency severity on 10 point VAS duration associated symptoms including aura characteristics associated disability with MIDAS score current medications for acute treatment and prophylaxis and their effectiveness
Consented subjects will receive weekly for one month an electronic headache diary to report headache days of that prior week by day and date functional rating scale pain intensity associated symptoms location of headache any missed workschoollife activity days acute medications used and clinic or transfusion center or emergency room visits for headache
After the one-month run-in the research coordinators will contact the subjects to affirm that they are now ready for an injection when they get their next acute migraine that is at least 510 severity on a Monday through Friday and ask them not to take their usual acute migraine rescue treatment unless that usually only blunts the pain to no less than 510
The subject will then call to be scheduled in our Procedure Clinic on a Monday through Friday when they have a typical acute migraine Their appointment will be scheduled on that same half-day with one of the Co-Is or PI and the appointment reason noted as acute migraine for nerve blocks If no slot is available within 24 hours they will encourage the subject to care for their migraine in their usual way and to call again with the next headache later that month
A brief interval history will be obtained by the investigator at the time of the appointment to confirm the details on an interval history questionnaire filled out by the patient earlier that day Randomization codes generated by the statistician and kept in sealed opaque envelopes in the Procedure Clinic in a sequential order numbered 1 - 60 will be opened by the physician investigator performing the injection at the time of the visit Block randomization will be utilized with random block sizes to provide balanced numbers in each group Subjects in the GONBs group will then receive bilateral GONBs for a total of 2 blocks Subjects in the MPNBs group will receive 10 nerve blocks to include greater occipital lesser occipital auriculotemporal supraorbital and supratrochlear nerves Investigators performing the blocks will only use neutral language to ensure that no bias is created by implying the subjects are only getting the GONBs or are getting all of the blocks not just a couple
Headache pain scores will be obtained from each subject at baseline and every 5 minutes after completing the first injection until 5 minutes after anesthesia is verified in all intended to be blocked nerve distributions Any residual headache pain present 10 minutes after injections are completed will be identified and recorded by scalp location central back of head lateral back of head temples forehead central forehead above the nose and sidedness left or right or both and anesthesia in those nerve distributions assessed If there is pain and lack of anesthesia in the dermatomal distributions of nerves not intended to be blocked the investigator will affirm the findings as ok good Any residual sensation to pain on pinprick in a nerve distribution intended for block will be re-blocked Any repeated blocks will be recorded in the procedure note Only anesthetic will be used for repeat blocks Nerve blocks will be reperformed in the sequence listed below until all intended nerve blocks are verified VAS pain scores will be recorded until 20 minutes after the last nerve intended for block is proven anesthetic
A questionnaire will be sent to each subject one day after their nerve block to ask them if they had complete headache relief whether the headache came back later when the anesthesia wore off their headache pain score that day day after the nerve blocks and to assess side effects of the PNBs to include pain bruising transient visual or facial motor changes
Subjects will be sent an electronic headache seven-day diary weekly for 3 months beginning 1 week after their nerve blocks to report the days of that prior week they had a headache acute medications used if any a functional rating scale maximal pain intensity each day headache associated symptoms any missed workschoollife activity days and any clinic or transfusion center or emergency room visits for headache
The primary outcome variable will be complete regression of headache pain on the day of PNBs as defined by VAS This will be assessed both by pain score and scalp location central back of head lateral back of head temples forehead central forehead above the nose and sidedness left or right or both Neck pain as commonly seen in migraine and other headache disorders will not be counted as headache pain Secondary outcome variables will be degree of prophylaxis of future headaches in terms of reduction in severity and frequency from historical severity and frequency of the subjects headaches and reduction in lost days of workschoollife events vs lost days of workschoollife events during the month pre-injection and clinicemergency roomtransfusion clinic visits for headache vs those in the one month prior to PNBs
Blinding
This will be a pragmatic randomized comparison trial GONBs and MPNBs will act as the treatment arms Research subjects will be informed that they are in a trial of nerve blocks in treatment and prevention of migraine headache and may receive up to 10 nerve blocks The language of consenting will seek to minimize bias by seeking to avoid suggesting that more blocks are better than less as follows There are small and large nerves all over the front back and sides of your head that can contribute to a migraine headache In this study subjects will get nerve blocks in various combinations of one or two or up to 10 nerves at a time The nerves blocked may or may not respond to the location of your pain
Intervention
Subjects will be randomized to receive either GONBs or MPNBs in the following methods
Greater occipital nerve GON blocks will be performed with head of patient prone on the table footrest with each block containing a mixture of 125 ml bupivacaine 05 and 20 mg methylprednisolone for GONB only or 10 mg for MPNB so then getting 40 mg total in both groups administered by a 3 ml syringe with a ¾ 30g needle The blocks will be performed in the following sequence until GON nerve distribution anesthesia is obtained 2 cm inferior and 2 cm lateral to the inion or lacking an occipital protuberance a central point of their occiput that is 3 cm from the midline nuchal edge will be assigned as inion hereafter called inion or failing to achieve anesthesia an anesthetic only injection at 22 of the distance from the inion to the mid-inferior mastoid as per Loukas et al 2006 or failing to achieve nerve block at the second location after 10 minutes an anesthetic only injection at 3 cm inferior and 1 cm lateral to the inion
Lesser occipital nerve LON blocks will be performed with the head of patient prone on the table footrest with each block w 125 ml bupivacaine 05 and 10 mg methylprednisolone administered by a 3 ml syringe and a ¾ 30g needle in the following sequence until LON nerve distribution anesthesia is obtained 30 of the distance from mid-inferior mastoid to inion determined location and location confirmed to be over cranium and failing to achieve anesthesia an anesthetic only injection into the sulcus just posterior to the mastoid and failing to achieve anesthesia with the first two locations after 10 minutes an anesthetic only injection at a location just 3-4 mm medial to the first 2 will be chosen that is over cranium
Auriculotemporal nerve ATN blocks will be performed with patient supine with each block containing 1 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and a 30g ¾ needle until ATN nerve distribution anesthesia is obtained Location of the first block attempt will be in the superior edge of the tragus fold formed by forward displacement of the tragus just superior to the ATN neuroforamen at the superior posterior fossa of the maxillas TMJ and 3-4 mm posterior to the temporal artery Location of the second block attempt if not anesthetic after 10 minutes will be 2-3 mm anterior of the anterior superior edge of the helix at a depth of ½ cm
Supraorbital nerve SON blocks will be performed with patient supine with each block containing 1 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and a 30g ¾ needle until SON nerve distribution anesthesia is obtained Any injected site will be held firmly afterwards for at least 2 minutes and longer if bleeding persists Location of the first block attempt will be 025 cm above the supraorbital rim along a vertical line drawn through the medial iris of a forward gazing eye marked with ear speculum tip prepped with chlorhexidine-alcohol and injected tightly against the cranium so as to in part provide subgaleal infusion to get the deep branch of the SON that may be subgaleal 05 ml just 025 cm superior to the supraorbital rim at the marked location and then another 05 ml injected just inferior to the supraorbital rim after walking the needle tip along the same vertical line off the edge of the supraorbital ridge injected perpendicular through eyebrow displaced inferiorly with finger under rim firmly to prevent upper lid edema from the injection or a scar in the skin only the eyebrow at an additional depth of 2 mm below the rim immediately withdrawn and firm pressure applied to both sites with flexed tip digit for 2 minutes to prevent ecchymosis from the supraorbital artery with additional pressure applied as needed if still bleeding Location of the second block attempt if not anesthetic after 10 minutes will be just medial or lateral to the first depending on which branch is not successfully blocked by the first attempt
Supratrochlear nerve STN blocks will be performed with patient supine with each block containing 05 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and 30g ¾ needle and repeated as needed The site will be held firmly afterwards for at least 2 minutes and longer if bleeding persists Only one location is needed for this block since it essentially never misses and the STN neuroforamen at a location ½ of the distance from the SON to the inner canthus of the eye is easily palpable in everyone
Time to complete the GONBs or MPNBs will be recorded along with any need for repeat injections specifying where they were repeated in the procedure note Headache VAS pain score will be obtained at 5 10 15 20 and in 5-minute intervals thereafter until all intended nerves are blocked as verified by pin-prick anesthesia
Human Subject Protection
Informed consent will be obtained from all subjects by research study coordinators This study with PNBs poses moderate risk of transient pain bleeding and bruising low risks of infection allergic reaction scarring hypo or hyperpigmentation dizziness or light-headedness or even fainting low risk of dermal atrophy skin dimpling or focal hair loss of a few mm around the occipital nerve block sites from the steroid rare cases of transient 6-8 hour facial nerve palsy if auriculotemporal block is placed too far inferior and anterior to the location intended and a risk of inefficacy meaning the nerve blocks dont help the headache pain Other risks mentioned in the literature are specific to errors in judgment and care egs a case of coma resulted from doing a GON block on a patient who had had a craniotomy and so the injectate traveled intracerebral Total steroid dose will be 40 mg for the GONB arm and 40 mg for the MPNB arm doses commonly well-tolerated for a variety of depo-steroid uses
Since both GONBs and MPNBs are presently standard of care for different consultants in different departments at our institution safety monitoring will be through assessment of post-injection anesthesia and compliance with injection and anesthesia assessment technique and assuring repeat injection to the point of anesthesia to ensure both safety and data validity
Conduct of the Study
The study will run until all subjects in each arm have received their nerve blocks and completed the 12-week post-injection follow up
Aims purpose or objectives
Compare whether anesthetizing multiple peripheral nerves of the scalp also known as multiple peripheral nerve block MPNB provides more acute headache pain relief than greater occipital nerve block GONB alone
Compare whether MPNB provides better headache prophylaxis than GONB alone measured monthly for three months
Determine whether there are fewer missed workschoollife activity days measured monthly for three months following nerve block for patients who receive MPNB compared to patients who receive GONB
Compare whether there are fewer Emergency RoomClinic visits for headache measured monthly for three months follow up for patients who receive MPNB compared to patients who receive GONB
Background
Peripheral nerve blocks PNBs have been studied in randomized trials and have proven beneficial and safe to varying degrees in the treatment of episodic migraine Most of these studies have evaluated GONBs two have looked at the combination of GONB and supraorbital nerve block SONB No study to date measuring pain relief in acute migraine and prophylaxis reported scalp anesthesia thus making conclusions about effect size of an actual nerve block on acute headache and prophylaxis or conclusions about optimal method medication dosages and frequency of blocks difficult
The PI has observed in his experience over 17 years administering many thousands of peripheral nerve blocks at MCR that essentially all patients get complete acute headache relief and most get durable prophylaxis for months if nerve blocks are administered in the distribution of a patients presenting headache and anesthesia is confirmed and documented in all nerves in the scalp distribution of the headache as many as 12 PNBs per patient to include bilateral greater occipital lesser occipital auriculotemporal supraorbital supratrochlear nerves and infraorbital nerves
In this study we will be randomizing patients to receive either GONBs alone or MPNBs to include all 10 scalp nerves and excluding patients with facial pain in the infraorbital nerve distribution during migraines
Study Design and Methods
Methods
Subjects with EMR documented episodic migraine headaches defined as 14 or less headache days per month frequency of which can be assessed at the time of initial discussion with the study coordinator will be recruited from our local patient population Study coordinators will then schedule a screening phone visit to explain the study and validate inclusionexclusion criteria and obtain written consent either digitally in person or eConsent and enroll the subject in the study
The research coordinator will then provide each subject with an initial questionnaire to obtain baseline data including episodic migraine headache diagnosis history of secondary headache causes location of their usual headache where in the head it starts and the progression frequency severity on 10 point VAS duration associated symptoms including aura characteristics associated disability with MIDAS score current medications for acute treatment and prophylaxis and their effectiveness
Consented subjects will receive weekly for one month an electronic headache diary to report headache days of that prior week by day and date functional rating scale pain intensity associated symptoms location of headache any missed workschoollife activity days acute medications used and clinic or transfusion center or emergency room visits for headache
After the one-month run-in the research coordinators will contact the subjects to affirm that they are now ready for an injection when they get their next acute migraine that is at least 510 severity on a Monday through Friday and ask them not to take their usual acute migraine rescue treatment unless that usually only blunts the pain to no less than 510
The subject will then call to be scheduled in our Procedure Clinic on a Monday through Friday when they have a typical acute migraine Their appointment will be scheduled on that same half-day with one of the Co-Is or PI and the appointment reason noted as acute migraine for nerve blocks If no slot is available within 24 hours they will encourage the subject to care for their migraine in their usual way and to call again with the next headache later that month
A brief interval history will be obtained by the investigator at the time of the appointment to confirm the details on an interval history questionnaire filled out by the patient earlier that day Randomization codes generated by the statistician and kept in sealed opaque envelopes in the Procedure Clinic in a sequential order numbered 1 - 60 will be opened by the physician investigator performing the injection at the time of the visit Block randomization will be utilized with random block sizes to provide balanced numbers in each group Subjects in the GONBs group will then receive bilateral GONBs for a total of 2 blocks Subjects in the MPNBs group will receive 10 nerve blocks to include greater occipital lesser occipital auriculotemporal supraorbital and supratrochlear nerves Investigators performing the blocks will only use neutral language to ensure that no bias is created by implying the subjects are only getting the GONBs or are getting all of the blocks not just a couple
Headache pain scores will be obtained from each subject at baseline and every 5 minutes after completing the first injection until 5 minutes after anesthesia is verified in all intended to be blocked nerve distributions Any residual headache pain present 10 minutes after injections are completed will be identified and recorded by scalp location central back of head lateral back of head temples forehead central forehead above the nose and sidedness left or right or both and anesthesia in those nerve distributions assessed If there is pain and lack of anesthesia in the dermatomal distributions of nerves not intended to be blocked the investigator will affirm the findings as ok good Any residual sensation to pain on pinprick in a nerve distribution intended for block will be re-blocked Any repeated blocks will be recorded in the procedure note Only anesthetic will be used for repeat blocks Nerve blocks will be reperformed in the sequence listed below until all intended nerve blocks are verified VAS pain scores will be recorded until 20 minutes after the last nerve intended for block is proven anesthetic
A questionnaire will be sent to each subject one day after their nerve block to ask them if they had complete headache relief whether the headache came back later when the anesthesia wore off their headache pain score that day day after the nerve blocks and to assess side effects of the PNBs to include pain bruising transient visual or facial motor changes
Subjects will be sent an electronic headache seven-day diary weekly for 3 months beginning 1 week after their nerve blocks to report the days of that prior week they had a headache acute medications used if any a functional rating scale maximal pain intensity each day headache associated symptoms any missed workschoollife activity days and any clinic or transfusion center or emergency room visits for headache
The primary outcome variable will be complete regression of headache pain on the day of PNBs as defined by VAS This will be assessed both by pain score and scalp location central back of head lateral back of head temples forehead central forehead above the nose and sidedness left or right or both Neck pain as commonly seen in migraine and other headache disorders will not be counted as headache pain Secondary outcome variables will be degree of prophylaxis of future headaches in terms of reduction in severity and frequency from historical severity and frequency of the subjects headaches and reduction in lost days of workschoollife events vs lost days of workschoollife events during the month pre-injection and clinicemergency roomtransfusion clinic visits for headache vs those in the one month prior to PNBs
Blinding
This will be a pragmatic randomized comparison trial GONBs and MPNBs will act as the treatment arms Research subjects will be informed that they are in a trial of nerve blocks in treatment and prevention of migraine headache and may receive up to 10 nerve blocks The language of consenting will seek to minimize bias by seeking to avoid suggesting that more blocks are better than less as follows There are small and large nerves all over the front back and sides of your head that can contribute to a migraine headache In this study subjects will get nerve blocks in various combinations of one or two or up to 10 nerves at a time The nerves blocked may or may not respond to the location of your pain
Intervention
Subjects will be randomized to receive either GONBs or MPNBs in the following methods
Greater occipital nerve GON blocks will be performed with head of patient prone on the table footrest with each block containing a mixture of 125 ml bupivacaine 05 and 20 mg methylprednisolone for GONB only or 10 mg for MPNB so then getting 40 mg total in both groups administered by a 3 ml syringe with a ¾ 30g needle The blocks will be performed in the following sequence until GON nerve distribution anesthesia is obtained 2 cm inferior and 2 cm lateral to the inion or lacking an occipital protuberance a central point of their occiput that is 3 cm from the midline nuchal edge will be assigned as inion hereafter called inion or failing to achieve anesthesia an anesthetic only injection at 22 of the distance from the inion to the mid-inferior mastoid as per Loukas et al 2006 or failing to achieve nerve block at the second location after 10 minutes an anesthetic only injection at 3 cm inferior and 1 cm lateral to the inion
Lesser occipital nerve LON blocks will be performed with the head of patient prone on the table footrest with each block w 125 ml bupivacaine 05 and 10 mg methylprednisolone administered by a 3 ml syringe and a ¾ 30g needle in the following sequence until LON nerve distribution anesthesia is obtained 30 of the distance from mid-inferior mastoid to inion determined location and location confirmed to be over cranium and failing to achieve anesthesia an anesthetic only injection into the sulcus just posterior to the mastoid and failing to achieve anesthesia with the first two locations after 10 minutes an anesthetic only injection at a location just 3-4 mm medial to the first 2 will be chosen that is over cranium
Auriculotemporal nerve ATN blocks will be performed with patient supine with each block containing 1 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and a 30g ¾ needle until ATN nerve distribution anesthesia is obtained Location of the first block attempt will be in the superior edge of the tragus fold formed by forward displacement of the tragus just superior to the ATN neuroforamen at the superior posterior fossa of the maxillas TMJ and 3-4 mm posterior to the temporal artery Location of the second block attempt if not anesthetic after 10 minutes will be 2-3 mm anterior of the anterior superior edge of the helix at a depth of ½ cm
Supraorbital nerve SON blocks will be performed with patient supine with each block containing 1 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and a 30g ¾ needle until SON nerve distribution anesthesia is obtained Any injected site will be held firmly afterwards for at least 2 minutes and longer if bleeding persists Location of the first block attempt will be 025 cm above the supraorbital rim along a vertical line drawn through the medial iris of a forward gazing eye marked with ear speculum tip prepped with chlorhexidine-alcohol and injected tightly against the cranium so as to in part provide subgaleal infusion to get the deep branch of the SON that may be subgaleal 05 ml just 025 cm superior to the supraorbital rim at the marked location and then another 05 ml injected just inferior to the supraorbital rim after walking the needle tip along the same vertical line off the edge of the supraorbital ridge injected perpendicular through eyebrow displaced inferiorly with finger under rim firmly to prevent upper lid edema from the injection or a scar in the skin only the eyebrow at an additional depth of 2 mm below the rim immediately withdrawn and firm pressure applied to both sites with flexed tip digit for 2 minutes to prevent ecchymosis from the supraorbital artery with additional pressure applied as needed if still bleeding Location of the second block attempt if not anesthetic after 10 minutes will be just medial or lateral to the first depending on which branch is not successfully blocked by the first attempt
Supratrochlear nerve STN blocks will be performed with patient supine with each block containing 05 ml of bupivacaine 05 without steroid administered by a 3 ml syringe and 30g ¾ needle and repeated as needed The site will be held firmly afterwards for at least 2 minutes and longer if bleeding persists Only one location is needed for this block since it essentially never misses and the STN neuroforamen at a location ½ of the distance from the SON to the inner canthus of the eye is easily palpable in everyone
Time to complete the GONBs or MPNBs will be recorded along with any need for repeat injections specifying where they were repeated in the procedure note Headache VAS pain score will be obtained at 5 10 15 20 and in 5-minute intervals thereafter until all intended nerves are blocked as verified by pin-prick anesthesia
Human Subject Protection
Informed consent will be obtained from all subjects by research study coordinators This study with PNBs poses moderate risk of transient pain bleeding and bruising low risks of infection allergic reaction scarring hypo or hyperpigmentation dizziness or light-headedness or even fainting low risk of dermal atrophy skin dimpling or focal hair loss of a few mm around the occipital nerve block sites from the steroid rare cases of transient 6-8 hour facial nerve palsy if auriculotemporal block is placed too far inferior and anterior to the location intended and a risk of inefficacy meaning the nerve blocks dont help the headache pain Other risks mentioned in the literature are specific to errors in judgment and care egs a case of coma resulted from doing a GON block on a patient who had had a craniotomy and so the injectate traveled intracerebral Total steroid dose will be 40 mg for the GONB arm and 40 mg for the MPNB arm doses commonly well-tolerated for a variety of depo-steroid uses
Since both GONBs and MPNBs are presently standard of care for different consultants in different departments at our institution safety monitoring will be through assessment of post-injection anesthesia and compliance with injection and anesthesia assessment technique and assuring repeat injection to the point of anesthesia to ensure both safety and data validity
Conduct of the Study
The study will run until all subjects in each arm have received their nerve blocks and completed the 12-week post-injection follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None