Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
Phase: PHASE2
Conditions: Post-Dural Puncture Headache, Sphenopalatine Ganglion Block
Sponsor: Milton S. Hershey Medical Center

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HRP-592 - Protocol for Human Subject 
Research with Use of Test Article(s)
Protocol Title:
Effectiveness of Sphenopalatine ganglion block for Post-Dural Puncture Headache; A pilot study
Principal Investigator:
Name: Verghese T Cherian
Department:  Anesthesiology and Perioperative Medicine
Telephone: 717-531 6926
E-mail Address: vcherian@pennstatehealth.psu.edu 
Version Date:
 November 20, 2019
Clinicaltrials.gov Registration #:
NCT03430531
Important Instructions for Using This Protocol Template:
1.
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” 
page, item 7. 
2.
This template is provided to help investigators prepare a protocol that includes the necessary information needed 
by the IRB to determine whether a study meets all applicable criteria for approval. 
3.
Type your protocol responses below the gray instructional boxes of guidance language.  If the section or item is 
not applicable, indicate not applicable.
4.
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, delete the 
instructional boxes from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  For all 
other research, do not delete the instructional boxes from the final version of the protocol.
5.
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the Study 
Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes. 
If you need help…
University Park and other campuses:
Office for Research Protections Human Research Protection Program
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Hershey Medical Center:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building Room 1140)
Phone: 717-531-5687
Fax number: 717-531-3937
Email: irb-hspo@psu.edu
Table of Contents
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1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Confidentiality, Privacy and Data Management
10.0
Data and Safety Monitoring Plan
11.0
Risks
12.0
Potential Benefits to Subjects and Others
13.0
Sharing Results with Subjects
14.0
Subject Stipend (Compensation) and/or Travel Reimbursements
15.0
Economic Burden to Subjects
16.0
Resources Available
17.0
Other Approvals
18.0
Multi-Site Research
19.0
Adverse Event Reporting
20.0
Study Monitoring, Auditing and Inspecting
21.0
Future Undetermined Research: Data and Specimen Banking
22.0
References
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1.0
Objectives
1.1
Study Objectives
To study the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-
dural puncture headache (PDPH).
1.2
Primary Study Endpoints
1. To study the effectiveness of SP ganglion block in relieving post-dural puncture headache in 
terms of 
a.
Number of subjects who get relief of pain
b. The onset time to pain relief after application of block
c.
The duration of pain relief
d. The incidence of recurrence of post-dural puncture headache
1.3
Secondary Study Endpoints
1. To monitor any complications due to SP ganglion block
2. To measure patient satisfaction
3. To monitor any residual effects at 1 months after the SP block 
2.0
Background
2.1
Scientific Background and Gaps
Lumbar puncture is a commonly performed diagnostic procedure in medicine and also for 
anesthesia. Inadvertent dural puncture can occur during epidural anesthesia and placement of an 
epidural catheter. Headache after a dural puncture is not uncommon and is excruciatingly 
painful. Most often it is self-limited and the pain subsides within 1-2 weeks. However, if left 
untreated, it can lead to considerable morbidity including chronic neck and back pain, subdural 
hematoma, seizures and even death. 
According to the Headache Classification Committee of the International Headache Society, 
headache after lumbar puncture is defined as “bilateral headaches that develop within 7 days 
after a lumbar puncture and disappears within 14 days. The headache worsens within 15 min of 
resuming the upright position, disappears or improves within 30 min of resuming the recumbent 
position”. This definition helps to avoid confusion with migraine or simple headache after 
lumbar puncture.
Currently, the standard practice to manage this headache is to do an epidural ‘blood-patch’, 
wherein an anesthesiologist performs an epidural puncture in the lumbar spine after numbing the 
skin and subcutaneous tissue with 2-3 ml of 2% lidocaine and injects 20-30ml of the patient’s 
blood into the epidural space. The intention is for the blood to clot and seal the dural puncture. 
This is effective about 90% of the time and can be repeated if it fails. Introduction of infection, 
arachnoiditis, or another inadvertent dural puncture are possible complications. Some patients 
opt not to have the epidural blood patch for fear of another inadvertent dural puncture and choose 
the conservative management. 
The other forms of therapy are strict bed rest for up to 7 days, hydration, caffeine, and epidural 
saline infusion. There are case reports of managing PDPH with administration of ACTH.
There are a few case reports about use of SP ganglion block for PDPH but no prospective studies 
looking at onset, duration, side effects and long term follow up after Sphenopalatine ganglion 
block.
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2.2
Previous Data
Here at HMC, we have performed the SP ganglion block in two patients who could not be 
offered epidural blood patch because they were on anti-coagulants. The block was effective and 
both were back to normal activities of daily living within 24h.
2.3
Study Rationale
According to the Monro-Kellie hypothesis, within the confines of the cranium, the volume of 
CSF, blood and brain matter is kept in harmony. Changes in volume of any one will cause 
compensatory changes in one or both of the other. 
A dural puncture causes loss of CSF and this is compensated for by an increase in cerebral blood 
flow (CBF) by vasodilatation, which in turn causes headache. This vasodilatation is mediated by 
parasympathetic inputs that synapse in the Sphenopalatine ganglion. Blockade of this ganglion 
would reduce parasympathetic activity and mitigate the headache.
SP ganglion block has been used to treat migraine and cluster headaches.
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
1.
Age greater than or equal to 18 years
2.
Complains of symptoms suggestive of post-dural puncture headache
3.
Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural 
placement) within the previous 7 days
4.
Sex: male or female (including nursing females)
5.
Fluent in written and spoken English
3.2
Exclusion Criteria
The following groups of patients will be excluded
1.
Those with a known history of hypersensitivity to local anesthetics of the amide type or to other 
components of GLYDO
2.
Those with any congenital or acquired, anatomical deformity of the nostril, which preclude 
performing the block
3.
Pregnant woman
4.
Tumors of the nasal cavity, sinuses, and nasopharynx
5.
Hypertension
6.
Hereditary hemorrhagic telangiectasia
7.
Use of anticoagulants such as clopidogrel, or warfarin
8.
Clotting factor (e.g. Von Willabrand’s disease (most common), Factor VIII deficiency (Hemophilia A), 
Factor IX deficiency (Hemophilia B), and Factor XI deficiency)
9.
History of epistaxis within the prior 30 days
10. Those who refuse to consent to participate in the study 
11. Patients who have had a failed epidural blood patch
12. Cognitive Impairment
13. Prisoner
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3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
If a patient consents to participate but cannot tolerate the procedure of SP block, then they will 
be removed from the study
3.3.2
Follow-up for withdrawn subjects
If the subject is withdrawn from the study, they will be offered other forms of therapy and 
followed up, if they allow.
4.0
Recruitment Methods
4.1
Identification of subjects
Patients who develop PDPH, both in-patients and those who arrive in the Emergency Department (ED) 
are referred to the Anesthesiologists-on-call, for management. A system will be set in place to inform 
one of the investigators when such a patient is referred. If suitable, one of the investigators will consent 
the patient and perform the block.
4.2
Recruitment process
When informed, one of the investigators will approach the patient and explain the study and if they are 
willing will consent them and perform the block.
4.3
Recruitment materials
None.
4.4
Eligibility/screening of subjects
Not applicable
5.0
Consent Process and Documentation
5.1
Consent Process 
 
5.1.1
Obtaining Informed Consent
5.1.1.1
Timing and Location of Consent
When identified as a potential candidate for the study in the ward or in the ED 
by one of the physician investigators.  The consent will be reviewed with the 
patient by one of the physician investigators.  The consent will be signed at that 
time if the subject is willing to participate in the research.
5.1.1.2
Coercion or Undue Influence during Consent
Patients that are enrolling in the study will be told that participation is voluntary 
and will not in any way compromise the standard of care that they will receive.
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Physician investigators will explain that the current standard treatment is bed 
rest, hydration and analgesics or an epidural blood patch. They will be free to 
choose any of the options.
5.1.2
Waiver or alteration of the informed consent requirement
A waiver of consent is requested to review medical record information to determine preliminary 
eligibility to participate in the research.
5.2
Consent Documentation
5.2.1
Written Documentation of Consent
The consent process will be documented in writing with the long form of consent 
documentation:
•
The current IRB approved consent form will be obtained.
•
We will verify that we are using the most current IRB-approved version of the study specific 
consent form and that the consent form is in language understandable to the subject.
•
A copy of the consent form will be provided to the subject.
5.2.2
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.)
Not applicable
5.3
Consent – Other Considerations 
5.3.1
Non-English Speaking Subjects
Not applicable
5.3.2
Cognitively Impaired Adults
5.3.2.1 Capability of Providing Consent
Not applicable
5.3.2.2
Adults Unable To Consent
Not applicable
5.3.2.3 Assent of Adults Unable to Consent
Not applicable
5.3.3
Subjects who are not yet adults (infants, children, teenagers) 
5.3.3.1 Parental Permission
Not applicable
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5.3.3.2 Assent of subjects who are not yet adults
Not applicable
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Not Applicable
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1 Plan to protect PHI from improper use or disclosure
Information is included in the Research Data Plan Form.
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers 
Study information will be destroyed after the research has ended and all 
institutional/regulatory requirements for data retention have been met
6.2.2
Explanation for why the research could not practicably be conducted without access to and 
use of PHI
Information must be obtained from the subject’s electronic medical record during recruitment 
to determine eligibility and, in some cases, to confirm information discussed with the subject in 
regards to their medical history
6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
The waiver is requested only for recruitment to determine subject eligibility to ensure that no 
medical conditions that fall into the exclusion criteria are present and would thus preclude 
enrollment.  This waiver will minimize the enrollment of subjects’ who may ultimately fail to 
meet the study inclusion/exclusion criteria.
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6.3
Waiver or alteration of authorization statements of agreement
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) 
per federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
7.0
Study Design and Procedures
7.1
Study Design
Open-labelled, single arm, pilot study
7.2
Study Procedures
7.2.1
Study Intervention: 
A urine pregnancy test will be done for all non-post-partum women.
Once the patient consents to participate in the study the following will be done.

The worst pain score (on a scale 0-10) that the patient experiences while sitting at the edge 
of the bed for 5 minutes, will be recorded.

An IV catheter will be placed and an infusion of IV fluid will be started, if the patient does 
not have already. 

Continuous ECG, pulse-oximeter and non-invasive blood pressure monitoring will be 
established and a skin temperature will be recorded. 

The patient will be placed in the supine position with the neck slightly extended.
Sphenopalatine block
Anatomy: The Sphenopalatine or the Pterygopalatine ganglion is a small (5 mm), 
parasympathetic ganglion located in the pterygopalatine fossa, posterior to the middle nasal 
turbinate. It is separated by a thin layer of connective tissue and mucosa from the nasal cavity. 
Lidocaine (2%) Swab Preparation:  
Use of cotton-tipped plastic applicator with 2% Lidocaine jelly applied (see section 7.4.6.3):  One 
2% lidocaine treated cotton-tipped applicator will be gently inserted into each nostril, along the 
floor of the nose. Slight rotatory motion of the applicator will be used to insert it as far as it goes 
with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position 
the applicator will be left undisturbed for 5 minutes. The swabs will be taken out and this will be 
repeated twice more, using fresh 2% lidocaine treated swabs. The whole procedure will take 
about 30 minutes.
After the procedure the patient will be asked for any side effects and if they are comfortable will 
be asked to sit up with their legs dangling over the side of the bed. If they can sit for about 15 
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minutes without pain and are hemodynamically stable, they will be asked to stand and walk. At 
any stage the headache returns or they cannot sit up or stand for any other reason, they will be 
made to lie down.
If the headache resolves, they will be discharged to go home, if acceptable by the primary 
physician. The patient will be encouraged to drink plenty of fluids and caffeinated drinks and get 
as much bed rest as possible for the next 3 days. 
After the patient has given informed consent, 2% Lidocaine jelly (Glydo) obtained from 
pharmacy supply, just like any other standard of care medication and will be 
administrated and documented as any other standard of care medication.  Post research 
intervention, a study team member will securely email Marisa Chew, Senior Representative 
Patient Accounts, at mchew@pennstatehealth.psu.edu within 24-48 hours with identifiers 
(MRN, FIN, and Date of Service).  She will manually pull the charge from the patient’s bill and 
direct the research charge to the Sponsor, in this case the Department of Anesthesiology and 
Perioperative Medicine.  
On Day 1, 2, and 7 after the procedure, one of the investigators will call them to ask a set of 
questions about the headache and any side effects. A follow up phone call, at 1 month after the 
SP ganglion block, will be made to ask for any residual headache or other symptoms and their 
satisfaction with the management. (Data Sheet)
 
If the headache does not get relieved, the patient will have the option to undergo an epidural 
blood patch or opt for a conservative management of bed rest, analgesics and oral fluids. These 
options will also be available if the headache were to recur after the patient goes home. 
We will also collect information (demographic details, past medical history, details of the 
procedure that led to the current headache) from the patient’s medical record for this research.
7.2.2
Post-treatment Days 1, 2,  7
Patients will be followed up by either a visit, if the patient is an in-patient, or by phone if the 
patient is at home.
Questionnaire – pain relief, residual pain (intensity and location), side effects, nasal bleeding
(See Data Sheet in supporting materials)
7.2.3
1 month Post-treatment
A follow up phone call at 1 month after the SP block will be made to ask for any residual 
headache or other symptoms and their satisfaction with the management.
7.3
Duration of Participation
The patients will be contacted on post –procedure Day 1, 2 and 7. During the phone call, they would be 
asked about their original complaints (headache, neck spasm), and if they have any new symptoms or 
discomforts.
The participants will be contacted by phone about 1 month after the procedure to ask if they have any 
residual neck or back pain or any other side effect. They will also be asked if they are satisfied with their 
management of PDPH
The follow-up phone calls will be made even if the SPG block fails and the subject opts for either an 
epidural blood patch or conservative management.
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7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1
Description
2% Lidocaine jelly (Glydo) is an approved local anesthetic agent permitted to be used over 
mucosal surfaces.
7.4.2
Treatment Regimen
A maximum of 6 mL of 2% lidocaine will be used which is within the therapeutic dose.
7.4.3
Method for Assigning Subject to Treatment Groups
It is an open label single arm study.
7.4.4
Subject Compliance Monitoring
The patient needs to comply with the telephonic conversation
7.4.5
Blinding of the Test Article
Not a blinded study
7.4.6
Receiving, Storage, Dispensing and Return 
7.4.6.1
Receipt of Test Article 
The 2% lidocaine jelly is dispensed as a single dose unit (syringe prefilled with 6 
mL of medication) and be obtained by and stored in the  inpatient Pharmacy 
according to their standard procedures.
7.4.6.2
Storage
The 2% lidocaine jelly will be obtained by and stored in the inpatient Pharmacy 
according to their standard procedures 
7.4.6.3
Preparation and Dispensing
The 2% lidocaine jelly is dispensed as a single dose unit (syringe prefilled with 6 
mL of medication) and will be obtained from the inpatient Pharmacy according 
to their standard procedures. The investigator will squirt 1ml of this medication 
onto the cotton tipped plastic applicator immediately prior to use.
7.4.6.4
Return or Destruction of the Test Article
These are single dose dispensers and unused drug will be discarded as per 
hospital policy
7.4.6.5
 Prior and Concomitant Therapy
Not applicable
8.0
Subject Numbers and Statistical Plan
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8.1
Number of Subjects
Thirty 
8.2
Sample size determination
Convenience Sample:  This is a pilot study and this number was selected to complete this study over one 
year.  The data collected will be used for a formal sample size calculation, if appropriate, to plan a larger 
study.
8.3
Statistical methods
It would be mainly descriptive statistics looking at time to onset of pain relief, the duration of pain relief, 
failure of the procedure to relieve PDPH, description and frequency of any side effects at one week and 
1 month.
The number of patients who do not get any or inadequate pain relief and if they need an epidural blood 
patch, it will be considered a failure of this technique.
9.0
Confidentiality, Privacy and Data Management 
See the Research Data Review Form
10.0 Data and Safety Monitoring Plan
10.1
Periodic evaluation of data
Every patient will be reviewed for any harmful effects due to the SP ganglion block
10.2
Data that are reviewed
Refer to above
10.3
Method of collection of safety information
Safety information will collected by interview of subjects at the time of intervention. Afterwards, safety 
information will be collected by telephone interview.
10.4
Frequency of data collection
Data will be collected at the time of intervention, Day 1, 2 and 7 post-procedural days and 1 month 
following intervention.
10.5
Individuals reviewing the data
Principal investigator – Verghese Cherian M.D
Co-investigator – Kofi Owusu MD
10.6
Frequency of review of cumulative data
Data will be reviewed after every 5 patients have undergone intervention.
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10.7
Statistical tests
It would be mainly descriptive statistics looking at time to onset of pain relief, the quantum of pain 
relief, the duration of pain relief, failure of the procedure to relieve PDPH, description and frequency of 
any side effects at one week and 1 month.
10.8
Suspension of research
Unexpected problems such as consistent trend of worsening morbidity in the immediate or long-term 
setting of study intervention
11.0 Risks
Insertion of the cotton swab stick into the nostril can cause:
- mild pressure or a feeling like you have to sneeze 
- brief mild discomfort or irritation in the nose 
- brief or quick burning sensation 
- bad taste in your mouth as some of the lidocaine may drip down into your mouth 
- tearing and a brief temperature change 
- temporary numbness in the throat related to a small amount of the lidocaine dripping into your mouth 
(This numbness should not last more than a few hours. During this time, it is safest if you avoid eating 
or drinking anything to avoid the risk of choking) 
- nasal bleeding or infection have been reported, in some cases may be severe bleeding 
- rarely, a temporary increase in pain has been reported
You may have temporary or no relief from procedure
There is a possibility of an allergic reaction to lidocaine.
Loss of confidentiality
Nursing mothers: The amount of lidocaine that may be absorbed into the blood stream, from this procedure, 
and excreted in the breast milk is minimal, and studies have shown that if nursing mothers undergoes even 
dental treatment with lidocaine, it is safe to continue breast-feeding.6
From the Glydo package insert:
Lidocaine is not contraindicated during labor and delivery. Lidocaine is secreted in human milk. Although, safety 
and effectiveness of lidocaine in pediatric patients have not been established, a study of 19 premature neonates 
where about 7mg/kg of lidocaine was used to lubricate intranasal tubes, the plasma levels of lidocaine was 
acceptable. 
However, if our subject is breast-feeding then we will advise her NOT to feed her baby for next 4h and to 
express the breast milk and discard.
12.0 Potential Benefits to Subjects and Others
12.1
Potential Benefits to Subjects
The SP ganglion block may reduce the PDPH
12.2
Potential Benefits to Others
If found effective, this could provide a less invasive alternative management for PDPH
13.0 Sharing Results with Subjects
Not applicable
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14.0 Subject Stipend (Compensation) and/or Travel Reimbursements
Not applicable
15.0 Economic Burden to Subjects
15.1
Costs 
The research will pay for the costs of the medication used for the SP ganglion block (Lidocaine 2%) and 
its administration.
15.2
Compensation for research-related injury
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers. 
16.0 Resources Available
16.1
Facilities and locations
Penn State Health Milton S. Hershey Medical Center, Hershey PA
16.2
Feasibility of recruiting the required number of subjects
Over a 1-year period, the study would have access to approximately 50 potential subjects.
16.3
PI Time devoted to conducting the research
The PI is allotted academic time for research and other scholarly activities
16.4
Availability of medical or psychological resources
All resources and facilities of HMC are available to subjects on study.
16.5
Process for informing Study Team
Each member of the study will complete CITI training. The procedure will be done by or under 
supervision of the PI. Additionally research team will meet monthly to review procedures and protocols.
17.0 Other Approvals
17.1
Other Approvals from External Entities
Not applicable
17.2
Internal PSU Committee Approvals
Check all that apply:
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  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA or 
gene therapy). 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that had 
been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of HRP-901 
- Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library.
  Clinical Research Center (CRC) Advisory Committee– All campuses – Research involves the use of 
CRC services in any way.  
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a copy 
of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library.
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
   Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The scientific 
review requirement may be fulfilled by one of the following: (1) external peer-review process; (2) 
department/institute scientific review committee; or (3) scientific review by the Clinical Research Center 
Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute Scientific Review 
Committee is required if the study involves cancer prevention studies or cancer patients, records and/or 
tissues. For more information about this requirement see the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/investigator 
18.0 Multi-Site Research
Not applicable
19.0 Adverse Event Reporting
19.1
Adverse Event Definitions
For drug studies, incorporate the following definitions into the below responses, as written:
Adverse event
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related
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Adverse reaction
Any adverse event caused by a drug
Suspected adverse 
reaction
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree 
of certainty about causality than “adverse reaction”.

Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event.
Serious adverse 
event or Serious 
suspected adverse 
reaction
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption 
of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction
An adverse event or suspected adverse reaction is considered “life-
threatening” if, in the view of either the Investigator (i.e., the study site 
principal investigator) or Sponsor, its occurrence places the patient or research 
subject at immediate risk of death.  It does not include an adverse event or 
suspected adverse reaction that had it occurred in a more severe form, might 
have caused death.
Unexpected 
adverse event or 
Unexpected 
suspected adverse 
reaction.  
An adverse event or suspected adverse reaction is considered “unexpected” if 
it is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified.
For device studies, incorporate the following definitions into the below responses, as written:
Unanticipated 
adverse device 
effect
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or IDE application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.
19.2
Recording of Adverse Events
Research subjects will be routinely questioned about adverse events during the procedure and in the 
follow-up phone calls.
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or its 
sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met:
•
The test finding is accompanied by clinical symptoms
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•
The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event.
•
The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study
•
The test finding is considered an adverse event by the investigator.
19.3
Causality and Severity Assessments
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event.
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history.
19.4
Reporting of Adverse Reactions and Unanticipated Problems to the FDA  
19.4.1 Written IND/IDE Safety Reports
Not applicable
19.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions
Not applicable
19.5
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
19.6
Unblinding Procedures
Not applicable
19.7
Stopping Rules
If the SP block is not effective in relieving the PDPH or is associated with morbidity due to the 
procedure, in the first 5 subjects, the study will be terminated.
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20.0 Study Monitoring, Auditing and Inspecting
20.1
Study Monitoring Plan
20.1.1 Quality Assurance and Quality Control
Not Applicable
20.1.2 Safety Monitoring
Not applicable
21.0 Future Undetermined Research: Data and Specimen Banking
Not applicable
22.0 References
1. Channabasappa, S., Manjunath, S., Bommalingappa, B., Ramachandra, S. and Banuprakash, S. (2017). 
Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache following 
spinal anesthesia. Saudi Journal of Anaesthesia, 11(3), p.362.
2. Cardoso, J., Sá, M., Graça, R., Reis, H., Almeida, L., Pinheiro, C. and Machado, D. (2017). 
Sphenopalatine ganglion block for postdural puncture headache in ambulatory setting. Brazilian Journal 
of Anesthesiology (English Edition), 67(3), pp.311-313.
3. Cohen, S., Sakr, A., Katyal, S. and Chopra, D. (2009). Sphenopalatine ganglion block for postdural 
puncture headache. Anaesthesia, 64(5), pp.574-575.
4. Patel P.,  Zhao R., Cohen S., Mellender S., Shah S., Grubb W. Sphenopalatine Ganglion Block (SPGB) 
versus Epidural Blood Patch (EBP) for accidental Postdural Puncture Headache (PDPH) in obstetric 
patients: a retrospective observation. Poster presentation at 32nd Annua Meeting of the American 
Academy of Pain Medicine: 2016 Feb 18 -21. Palm Springs (CA). Poster #145
5. Nair, Abhijit S., and Basanth K. Rayani. "Sphenopalatine ganglion block for relieving postdural 
puncture headache: technique and mechanism of action of block with a narrative review of efficacy." 
The Korean Journal of Pain, vol. 30, no. 2, 2017, p. 93.
6. Giuliani M, Grossi GB, Pileri M, Lajolo C, Casparrini G. Could local anesthesia while breast-feeding be 
harmful to infants? J Pediatr Gastroenterol Nutr. 2001 Feb;32(2):142-4.
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