Erector Spinae Plane Block Versus Control for Pain Control Following Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study
Phase: NA
Conditions: Nephrolithotomy, Percutaneous
Sponsor: University of Tennessee Medical Center

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Erector Spinae Plane Block versus Control for Pain Control Following Percutaneous 
Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study.
Primary Investigator:
Jason Buehler, MD
University of Tennessee Medical Center
1924 Alcoa Hwy Box 109
Knoxville, TN 37920
(865) 305-9220
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Study Summary
Title
Erector Spinae Plane Block versus Control for Pain Control Following 
Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo 
Controlled Study.
Methodology
Randomized, double-blind, controlled study
Study Duration
1 year 
Study Center(s)
University of Tennessee Medical Center
Objectives
Primary:   Determine if there is a significant effect on post percutaneous 
nephrolithotomy morphine milligram equivalents (MME) consumption with the 
usage of an ESP block vs. saline control.                                                                  
Secondary :   Determine if there is a significant effect on reported pain levels 
with the use of an ESP block vs. saline control in post percutaneous 
nephrolithotomies
Number of Subjects
128
Diagnosis and Main 
Inclusion/Exclusion Criteria
Inclusion Criteria 
All participants will require full consent, be willing and able to comply with all 
study requirements and will meet the following inclusion criteria:
-Adults, male and female greater than or equal to age 18 and undergoing non-
emergent percutaneous nephrolithotomy Monday-Friday from 6:00AM-
4:00PM.
-Female volunteers of childbearing potential will be required to provide a 
negative pregnancy test.
-Ability to understand and teach back consent for the procedure.
-Willingness to sign consent for procedure.
-English Speaking.
Exclusion Criteria
-Emergent surgery status.
-Local infection.
-Allergy to local anesthetics.
-Recreational drug use.
-Inability to provide informed consent.
-Pregnancy or breastfeeding.
-History of Guillain-Barre’ Syndrome.
-Underlying medical conditions that would pose a significant risk to the patient.
Study Product, Dose, Route, 
Regimen
The erector spinae plane block, while it is a standard procedure, is the 
independent variable for this study. The ESP block is an ultrasound-guided 
paraspinal fascial plane block that involves the injection of 30mL of 0.5% 
ropivacaine with 4mg of dexamethasone anterior to the erector spinae muscle 
and posterior to the thoracic transverse processes.
Study Endpoints
 Primary study endpoint is the opioid consumption (MME) in the first 24 hours 
postoperative.  Secondary study endpoints are hospital LOS, mean VAS score 
in the 24 hours after surgery, new persistent postoperative opioid use at 30 
days, and QoR-15 at 24, 48, and 168 hours.
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Protocol Version 1.5
Title: Erector Spinae Plane Block versus Control for Pain Control Following Percutaneous 
Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study.
Investigator names:
Jason Buehler, MD- PI
Aimee Pehrson, MPH- Study Coordinator
Mark Murray, MD
Jeff Staack, MD
Matthew Vance, MD
Adam Roth, MD
Elizabeth Driscoll, MD
Hannah Vega, MD
Eric Cox, MD
Wesley White, MD
Jonathan Angelle, MD
James Bienvenu, MD
Ryan Pickens, MD
Megan Hintz, Pharm-D
Chaney Graham Bass, FNP-BC
Savannah Kidd, PA-C
Location: University of Tennessee Health Science Center- Knoxville 
Objectives / Specific Aims 
The purpose of this study is to investigate the use of the erector spinae (ESP) 
block in reducing the morphine milligram equivalent (MME) consumption post 
percutaneous nephrolithotomy. 
Objectives:
1. Determine if there is a significant effect on post percutaneous 
nephrolithotomy MME consumption with the usage of an ESP block vs. saline 
control.
2. Determine if there is a significant effect on reported pain levels with the use of 
an ESP block vs. saline control in post percutaneous nephrolithotomies. 
Hypothesis: The Erector Spinae Plane Block will be associated with reduced opioid 
consumption in the first 24 hours compared to the control following percutaneous 
nephrolithotomy.
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Background and Significance:
Renal pain associated with percutaneous nephrolithotomy is a well-documented 
phenomenon due to sensory nerve transmission occurring through the renal nerve plexus, 
splanchnic nerves and thoracic sympathetic nerve ganglia. The erector spinae plane has 
the potential to provide a benefit of visceral analgesia through the spread of local 
anesthetic to the sympathetic fibers in the space between the thoracic vertebra [1, 2]. Due 
to this, the local anesthetic effects of the erector spinae plane block on renal visceral 
innervation may provide superior postoperative analgesia and in recent studies has shown 
a of decrease opioid consumption in the first 48 hours compared to control blocks [1, 3, 
4]. 
Current data from the University of Tennessee Medical Center:
1. Quality improvement (QI) data demonstrates an average time to first opioid in 
patients who received a ESP block at the time of their percutaneous 
nephrolithotomy is 15.5 hours; average first pain return is 15.3 hours; On a 
five point scale (0 totally dissatisfied, 5 completely satisfied), average patient 
satisfaction with pain control is a 4.8; 100% would request a repeat block if 
they had the surgery again.
The current procedure for determining if an ESP block should be used is as follows:
1. The surgeon identifies patients who may benefit from block placement.
2. The day of surgery, the risks and benefits of a block are presented to the patient 
by the anesthesiologist. 
3. If the patient decides on having a block placed, the anesthesiologist obtains 
consent for block placement.
4. Blocks are placed either in preoperatively or during surgery depending on the 
patient and the procedure. 
In this study, potential subjects will have the opportunity to review all pertinent 
information regarding the risks and benefits to receiving a nerve block prior to pre-
anesthesia testing so any questions can be answered before obtaining consent. 
Interventions to be studied: ESP versus Control Block in Percutaneous Nephrolithotomy
Erector Spinae Plane Block- Independent Variable
The erector spinae plane block, while it is a standard procedure, is the independent 
variable for this study. The ESP block is an ultrasound-guided paraspinal fascial plane 
block that involves the injection of 30mL of 0.5% ropivacaine with 4mg of 
dexamethasone anterior to the erector spinae muscle and posterior to the thoracic 
transverse processes.
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Figure 1. The Erector Spinae Block [5]
Approximately 20 ESP blocks are currently being performed per month at the University 
of Tennessee Medical Center for surgeries involving the thoracic cavity, kidney and/or 
flank
Potential Regional Anesthetic-related Complications: [1, 6]
2 cases of pneumothorax have been described in the literature.
Nerve Damage
Brusing and discomfort at injection site
Infection 
Headache
Hematoma at injection site
Persistent weakness
The following will be utilized to minimize the risk of complications:

Proper aseptic technique will be used to minimize risk of infection.

Proper positioning and ultrasound-guided technique will help minimize 
the risk of pneumothorax, hematoma at injection site, paralysis, and block 
failure.

Continuous monitoring of vital signs during surgery and in the PACU to 
assess for changes in clinical presentation. 

At the 48-h post operation phone call, study staff will assess for side 
effects. 
Benefits [1, 7, 8]: Whereas there are no specific benefits to the subjects for 
participating in the study it is hoped that we will be able to determine that an ESP 
block will be superior to the placebo and offer the following benefits
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
Reduction in opioid consumption.

Reduction in Visual Analogue Scale (VAS) pain score. 

Reduced hospital stay.

Prolonged analgesia.

Improved ventilation and tissue perfusion status.

Studies have demonstrated ESP safety and effectiveness with no cases of bleeding 
or hemodynamic effects currently identified [1].
Control/Placebo
The control block containing preservative free normal saline will be performed by 
a regional anesthesiologist. Post procedure analgesia will be available as ordered 
by the subject’s physician performing the percutaneous nephrolithotomy.
Study Endpoints

Primary study endpoint is the opioid consumption (MME) in the first 24 hours 
postoperative.

Secondary study endpoints are hospital length of stay (LOS), mean Visual Analog Scale 
(VAS) score in the 24 hours after surgery, new persistent postoperative opioid use at 30 
days, and QoR-15 at 24 hours, 48 hours, 7 days and 30 days.
Number of subjects
Based upon power analysis, sample size is 128 subjects undergoing an elective percutaneous 
nephrolithotomy with 64 participants in each arm of the study. 
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria will be determined through chart review, the history and 
physical at pre-anesthesia testing as well as the day of surgery, and the ability and 
willingness to sign consent.
Inclusion Criteria 
All participants will require full consent, be willing and able to comply with all 
study requirements and will meet the following inclusion criteria:

Adults, male and female greater than or equal to age 18 and 
undergoing non-emergent percutaneous nephrolithotomy Monday-
Friday from 6:00AM-4:00PM.

Female volunteers of childbearing potential will be required to provide 
a negative pregnancy test.
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
Ability to understand and teach back consent for the procedure.

Willingness to sign consent for procedure.

English Speaking.
Exclusion Criteria

Emergent surgery status.

Local infection.

Allergy to local anesthetics.

Recreational drug use.

Inability to provide informed consent.

Pregnancy or breastfeeding.

History of Guillain-Barre’ Syndrome.

Underlying medical conditions that would pose a significant risk to 
the patient.
Contraindications:
Contraindications are the contraindications for receiving a nerve block. They are 
determined through chart review and the history and physical at pre-anesthesia testing as 
well as the day of surgery. 
Absolute Contraindications

Lack of patient consent.

Skin infection at the site of needle insertion.
Relative Contraindications

Coagulopathy.

Systemic infection.

Anatomical distortion.

Neuropathy.
Drugs/Device usage within 7 Days of Randomization if any:

Anticoagulants 
Recruitment Methods
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
Participants will be recruited through chart review of potential subjects 
scheduled for a percutaneous nephrolithotomy. 

Through chart review, subjects who meet all inclusion and exclusion criteria 
will be selected to be asked to consent to enter the study. 
Consent process
The physician performing the surgery will approach potential subjects at their in-
office appointment prior to surgery. The physician will provide an overview of 
the study and a copy of the consent form to take home and read. The physician 
will:

Explain all the risks and benefits of the study.

Answer any questions at that time.
At the subjects’ pre-anesthesia testing appointment, a member from the 
supporting Research Staff will:

Explain all the risk and benefits of participation in the study.

Review the consent form and assess the subject’s ability to teach back in 
their own words the risks and benefits of the procedure, the ability to state 
their own decision, the ability to explain how the information applies to 
oneself, and the ability to compare and infer the outcomes of their choices.

Only obtain consent from the participant.
In order to decrease the possibility of coercion or undue influence, the research 
staff will discuss how pain will be controlled both within the study and outside of 
the study to ensure participants understand that post-operative pain will be treated 
according to their physician’s orders, regardless of study participation. Medical 
care will be provided in the event any unforeseen circumstance arises, regardless 
of study participation. 
For Cognitively Impaired Adults 
Decision making ability will be assessed when obtaining consent. Study personnel 
will assess for the subject’s ability to teach back in their own words the risks and 
benefits of the procedure, the ability to state their own decision, the ability to 
explain how the information applies to oneself, and the ability to compare and 
infer the outcomes of their choices.
Methodology 
This is a double-blind, randomized control trial involving 128 subjects undergoing an 
elective percutaneous nephrolithotomy. All subjects who meet all inclusion and exclusion 
criteria will be equally randomized on the day of the procedure by operating room 
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pharmacy into either the ESP block or the control block. An interim analysis at the 
sample size required for a large effect size (n = 52, with n = 26 in each treatment arm) 
will be performed. In order to blind the anesthesiologist performing the block, the control 
arm will be equally randomized by the pharmacist at the time of distributing the pre-filled 
syringes for the ESP block procedure. Randomization will occur with the use of a random 
number generator with 1:1 ESP:Control allocation ratio.
Subjects will be followed at Pre-op and the 24-h, 48-h, 7 days and 30 days post 
operatively to assess the quality of recovery utilizing the Quality of Recovery-15 (QoR-
15) questionnaire, VAS pain scale, and opioid consumption. Intraoperative MMEs, 
PACU MMEs, total MME’s, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 
hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be 
documented in patient chart, reviewed by study personnel and uploaded into a password 
protected database on the UTMCK server. 
Research Procedures:
All aspects of the study and consent forms will be IRB approved prior to implementation. 
Potential candidates will be selected for consent based on chart review and surgery scheduling.

The Surgeon will initially approach potential subjects and provide them with a copy of 
the consent form to take home and read prior to pre-anesthesia testing.

At the subject’s pre-anesthesia testing appointment, the research staff will explain the 
risks and benefits of the study, answer any questions, and obtain consent to participate.

The Biostatistician will randomize the subjects with a random number generator. Once 
randomized, a blinded package labeled "ESP" or “Control” will be delivered to the 
regional anesthesia team containing the following:
ESP
Active group: 
1.
One 30mL syringe containing 29mL of 0.5% ropivacaine and 4mg of 
dexamethasone- labeled "ESP Block"
2.
One 30mL syringe containing 30mL of preservative free normal saline- 
labeled "wound infiltration"
Sham group
1.
One 30mL syringe containing 30mL of 0.5% ropivacaine- labeled "wound 
infiltration"
2.
One 30mL syringe containing 30mL of preservative free normal saline- 
labeled "ESP Block"
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
The pharmacist will create a table pre-populated with the randomization 
assignments with space to fill out patient information and medication 
information on the day of surgery. This chart will be in paper form and kept in a 
research binder in the OR pharmacy. When a patient is consented for the RCT, 
the treatment group will be chosen based on the numbers assigned a priori. Each 
qualifying patient will be documented on the subsequent row in the table, 
maintaining the original order of randomization as dictated by the statistician. 
Based on the assignment, the pharmacy technician will be instructed as to which 
products to make in the sterile hood. The pharmacist will verify that the 
products were made appropriately and will label the syringes according to 
assignment.

Operating room pharmacy will hand the anesthesiologist a blinded package with one 
prefilled syringe for the regional block that will either contain 30mL of 0.5% ropivacaine 
with 4mg of dexamethasone or preservative free normal saline.

The regional anesthesiologist will perform the ESP block using standard protocols and 
procedures.

Age, BMI, duration of operation, EBL, intraoperative MMEs, PACU MMEs, 48 hours 
post-operative MMEs, total MME’s, FLACC scores at 30 minutes/1 hour VAS scores at 
1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be 
documented in patient chart and reviewed by study personnel.

QoR-15, MME consumption, and VAS will be assessed at Pre-op, 24-h, 48-h, 7 and 30 
days by study staff. Data will be uploaded into a database kept on secured password 
protected computers on the UTMCK server.

All patient identifiers will be removed prior to data analysis.  
Non- Research Procedures:

Consent for anesthesia will be obtained prior to performing any regional 
or general anesthesia.

Standard safety and aseptic measures prior to performing for all regional 
blocks will be followed.

Pregnancy test for all women with child bearing potential.
ESP Block Procedure:

The subject will be put to sleep with general anesthesia. 

The anesthesiologist will identify proper anatomy for the block. 

Lidocaine will be used to numb the injection site.

The Anesthesiologist will use ultrasound-guided technique and inject 
30mL of 0.5% ropivacaine with 4mg of dexamethasone or saline placebo 
control into the erector spinae muscle, superficial to the tips of the thoracic 
transverse processes
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Procedures performed to lessen the probability or magnitude of risks:
1. Proper aseptic technique will be used to minimize risk of infection.
2. Proper positioning and ultrasound-guided technique will help minimize the risk of 
pneumothorax, hematoma at injection site, paralysis, and block failure.
Data Collection:
Data will initially be collected to determine inclusion and exclusion criteria through chart 
review.
The day of procedures, a member of the study staff will interview the potential subjects 
and perform a pre-operative QoR-15 and VAS questionnaire.
Other data to be collected are: Age, BMI, duration of operation, estimated blood loss 
(EBL), intraoperative MMEs, PACU MMEs, 24 hours post-operative MMEs, total 
MME’s, FLACC scores at 30 minutes/1 hours and VAS scores at 1hour/2 hours/6 hours/, 
PACU LOS (length of stay), hospital LOS, and time to first flatus.
At 24 h, 48-h, 7 and 30 days post-operation, subjects will be contacted by study staff with 
repeat QoR-15 and VAS scores. Chart review will also take place to document opioid 
consumption. Data will be input into a secure, password protected database.
Tools Utilized:
Face, Legs, Activity, Cry, Consolability (FLACC) scale: This tool is used to express pain 
for individuals who are not able to communicate what their pain status is. 
Table 1. FLACC Scale
Quality of Recovery -15 (QoR-15) Questionnaire: This tool measures the quality of 
recovery after surgery and anesthesia through 15 outcome measure questions.
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Table 2. QoR-15 Patient Survey
Visual Analogue Scale (VAS): This tool measures pain intensity by associating a 
perceived pain numeric value with a facial expression of pain.
Figure 1. Visual Analog Scale
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Risks to subjects
Adverse event (AE) means any untoward medical occurrence associated with the use of a 
drug in humans, whether or not considered drug related.
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 or sponsor, its occurrence places the patient or 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.
Serious adverse event or serious suspected adverse reaction. An adverse event or suspected 
adverse reaction is considered "serious" if, 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.
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 or is not listed at the specificity or severity that has been observed; or, if an 
investigator brochure is not required or available, is not consistent with the risk 
information described in the general investigational plan or elsewhere in the current 
application, as amended 
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32)
The physical reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects are related to obtaining an ESP block and not 
specifically related the subjects’ participation in the research. These risks 
include:
Common Forseeable Risks:

Bruising and discomfort at injection site

Block Failure
Uncommon Forseeable Risks:
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Pneumothorax
Nerve Damage
Infection
Headache
Hematoma at injection site
Persistent weakness
Loss of Privacy
Unforeseeable risks are associated with the blocks themselves and are not related to study 
participation
Data Management 
Statistical Power/Sample Size
The researchers hypothesized a moderate effect size related to the difference in MMEs at 
24 hours associated with ESP versus Control. Using a two-tailed hypothesis, the effect 
size of d = 0.5, an alpha value of 0.05, a beta value of 0.20, and a 1:1 allocation ratio to 
the two treatment arms, a total of n = 128 participants would be needed for adequate 
power (n = 64 in each treatment arm). The researchers plan to perform an interim analysis 
at the sample size required for a large effect size (n = 52, with n = 26 in each treatment 
arm).
Statistical Methods
The statistical analysis for the study will be performed in an “intention-to-treat” fashion. Data 
missingness will be assessed using the MCAR (missing completely at random) analysis. 
Statistical assumptions of the statistical analyses will be assessed before choosing the correct 
statistical test (normality, homogeneity of variance, etc.).
Descriptive and frequency statistics will be used to describe the sample’s demographic and 
clinical characteristics. The following outcomes will be compared between the two treatment 
arms using either independent-samples t-test or Mann-Whitney U, depending upon the meeting 
of statistical assumptions: Age, BMI, duration of operation, EBL, intraoperative MMEs, PACU 
MMEs, 48 hours post-operative MMEs, total MME’s, FLACC scores at 30 minutes/1hour, VAS 
scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus, Quality 
of Recovery 15 scores at 48 hours post-operation, MMEs at 30 days post-discharge, and the 
primary outcome MMEs in first 24 hours post-operation. Chi-square analysis will be used to 
compare the treatment arms on the categorical parameters of interest, including gender, ASA 
status, and post-operative nausea/vomiting, readmission rates, and new persistent postoperative 
opioid use. Statistical significance will be assumed at an alpha value of 0.05 and all analyses will 
be performed using SPSS Version 26 (Armonk, NY: IBM Corp).
The Principal Investigator will be responsible to ensure the study is conducted in accordance with the 
protocol, Good Clinical Practice, applicable regulatory requirements, and that the data recorded is valid. 
To achieve this, the study will be continuously monitored and reviewed via a monthly monitoring log 
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(Appendix 1.) that addresses adverse events as well as protocol and regulatory adherence on a monthly 
basis by Dr. McLoughlin, Dr. Allen, and the Study Coordinator and submitted for review to the Principal 
Investigator  .  
The collection of personal patient information will be limited to the amount necessary to achieve 
the aims of this research, so that no unneeded sensitive information is being collected.  Data will 
be collected through chart review and medical records for inclusion criteria and follow-up. 
Pharmacy will maintain the code that identifies which patients receive which arm of the study 
while the Research Coordinator will maintain the decoder on a password protected computer. All 
hard copies of documents will be kept in a locked cabinet in the Research Coordinator’s office. 
All hard copy documents will be shred within six years after the completion of the study. Data 
will be input into the REDCAPS database stored on the University of Tennessee Medical Center 
server. When data is used for statistical analysis, it will be de-identified and input SPSS.
Withdrawal of Subjects 
Subjects will be withdrawn from the research without their consent, 
including stopping participation for safety reasons, if the appropriate 
anatomy cannot be safely identified on ultrasound at the time of the 
regional anesthetic block. 
Subjects will be withdrawn from the research without their consent, if any 
contraindications are present on the day of surgery.
All subjects have the right to withdraw from study participation at any 
time during the study. If a participant requests to withdraw prior to study 
completion, the data associated with that participant will be removed from 
the database and not utilized in statistical analysis. Subjects must notify 
study staff in writing, speak face-to-face, or call (865) 305-9220 within 
business hours (8:30 AM-4:30PM) in order to withdraw from the study. 
References
 1.
Tsui, B.C.H., et al., The erector spinae plane (ESP) block: A pooled review of 242 cases. Journal 
of clinical anesthesia, 2019. 53: p. 29-34.
2.
Govender, S., et al., The extent of cranio‐caudal spread within the erector spinae fascial plane 
space using computed tomography scanning in a neonatal cadaver. Pediatric anesthesia, 2020. 
30(6): p. 667-670.
3.
Ibrahim, M. and A.M. Elnabtity, Analgesic efficacy of erector spinae plane block in percutaneous 
nephrolithotomy: A randomized controlled trial. Der Anaesthesist, 2019. 68(11): p. 755-761.
4.
Dundar, G., et al., The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract 
On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, 
randomised, double-blind, placebocontrolled clinical trial. Urology journal, 2018. 15(6): p. 306-
312.
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5.
Kwon WJ, B.S., Sun WY, Erector Spinae Plane Block for Effective Analgesia after Total 
Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. Journal 
of Korean Med Sci, 2018. 33.
6.
De Cassai A, B.D., Correale C, Sandei L, Tulgar S, Tonetti T., Erector spinae plane block: a 
systematic qualitative review. Minerva Anestesiol, 2019. 85(3): p. 308-319.
7.
Tulger S., S.O., Ozer Z., Clinical experience of ultrasound-guided single and bi-level erector 
spinae plane block for
postoperative analgesia in patients undergoing thoracotomy. Journal of clinical anesthesia, 2018. 50: p. 
22-23.
8.
Ugras, M.Y., et al., Instillation of skin, nephrostomy tract, and renal puncture site with 
ropivacaine decreases pain and improves ventilatory function after percutaneous 
nephrolithotomy. J Endourol, 2007. 21(5): p. 499-503.
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Appendix 1. Monthly Monitoring Log
(Adapted from the CDC Monitoring Log and the King’s Health Partners)
Monthly Monitoring Log
Investigator and Trial Monitoring Visit Report IRB #
Trial Details
Trial Title:
Site Investigator Name:
Department:
Site:
PI:
Monitoring Summary
Date of Visit(s):
Report Produced on:
Follow-up Correspondence Sent:
Patient Recruitment Status
Confirmed
Randomised/Entered Study Arms:
Dropped Treatment due to Adverse Events:
Number of SAEs at Site To Date:
YES
NO
NA*
1.
INFORMED CONSENT AND SUBJECT STATUS
1.1. Does the Investigator maintain logs of screened and enrolled subjects, including subject 
identification log?
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Comments:
1.2. Has/have there been any subject(s) discontinued from treatment or from the clinical trial 
(include details of any discontinuation for non-serious adverse events)?
Comments: 
1.3. Has/have there been any subject(s) lost to follow-up (according to the protocol) since the 
last monitoring visit report?
Comments: 
2.
PROTOCOL ADHERENCE, MEDICAL RECORD REVIEW AND SDV
2.1. Did all the subjects reviewed meet the eligibility criteria? 
Comments:
2.2. Has/have there been any significant deviation(s) from the final version of the protocol 
and protocol amendment(s) (if any)? *List all deviations on the deviation log.
Comments: 
2.3.Have all SDV/data queries raised during this visit been resolved?
Comments: 
2.4.SAE/AE
Have all site SAEs, including follow up information, been appropriately reported to the Sponsor? Please list SAE 
status of all the reported SAEs and any outstanding queries. *A separate sheet can be attached to the report if 
appropriate.
Comments: 
SAE 
number
Status 
(Open/Close
d)
SDV 
perform
ed (Y/N)
Outstanding Queries
2.5. Have all Serious Adverse Events been appropriately reported to the PI?
Comments: 
IRB NUMBER: 4730
IRB APPROVAL DATE: 12/15/2020