The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
Phase: PHASE1
Conditions: Rib Fractures
Sponsor: Virginia Commonwealth University

COVER PAGE 
Study title:  The erector spinae plane block and its effect on respiratory status and pain management in 
rib fracture patients  
Principal investigator:  Bryant Tran, M.D. 
NCT number:  not yet assigned 
Virginia Commonwealth University Study ID number: HM20014264  
Date of document:  January 11, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The erector spinae plane block and its effect on respiratory status and pain management in rib 
fracture patients 
NCT number:  not available 
Date of document:  January 11, 2019 
 
 
2
STUDY DESIGN:  
The study will be a prospective, randomized, double-blinded, two-arm study, which will assess the effect 
of the ESP block on pulmonary function and pain management. The control group will receive a “sham” 
ESP injection with saline and the experimental group will an ESP injection with local anesthetic. Primary 
outcomes will measure change in vital capacity and change in pain score after the intervention.  
Notably, incorporation of a nerve block for rib fracture pain management is within standard of care but 
is not considered until other less invasive options have proven inadequate. The step-wise layered 
approach is as follows: initial therapy includes oral medications such as acetaminophen, non-steroidal 
anti-inflammatory drugs, and opioids such as oxycodone. If this is not adequate, intravenous 
medications are added, which include ketamine, dexmedetomidine, and opioids such as 
hydromorphone. Next, subcutaneous infiltration of local anesthetic may be considered. Finally, acute 
pain service consultation allows for evaluation of nerve block options such as epidural placement, 
paravertebral nerve block, or ESP block. Performance of an ESP block is considered within standard of 
care. The acute pain service consultation will trigger the initial screening process to determine patient 
eligibility for the study.  
PROTOCOL  
Consent will be obtained by one of the research investigators in the trauma intensive care unit, where 
medical management takes place for all patients with significant injuries that include rib fractures. A 
randomizer will be used to prepare envelopes that will designate which study arm the patient will be 
placed. After consent is obtained, each participant will be given a numerical designation that will allow 
for blinding but also allow for easy identification between study arms (data collection sheet attached). 
The investigator that performs consent and randomization will prepare the study medication; for the 
control group, the investigator will transfer saline from a vial into two 20cc injection syringes, and for 
the experimental group, the investigator will transfer 0.5% ropivacaine from a vial into two 20cc 
injection syringes. The syringes will be labeled as "rib fracture study medication" along with the 
numerical designation of the participant. The consenting investigator will deliver the medication 
syringes to the team that is performing the procedure.  
A second investigator will obtain baseline measurements and perform the procedure. Neither the 
second investigator nor the research participant will know the contents of the study medication. All 
equipment required for the ESP block will be brought to the participant's bedside. The participant will 
perform a baseline incentive spirometry (IS) exercise in a sitting position on the side of the bed; the  
participant will take the deepest breath possible by inhaling through the IS device, and the second 
investigator will record highest vital capacity volume that the patient can reach. The investigator will 
also record the participant's reported numerical pain score before the IS exercise and pain score after  

The erector spinae plane block and its effect on respiratory status and pain management in rib 
fracture patients 
NCT number:  not available 
Date of document:  January 11, 2019 
 
 
3
STUDY DESIGN (continued) 
the IS exercise (data collection sheet attached). These baseline measurements will be taken for research 
data collection and will not be documented in the patient's medical record.  
The process for performing the ESP block procedure is as follows: the patient will be placed in a seated 
position and vital sign monitors will be connected. Per standard of care, either an ICU nurse or acute 
pain service nurse will be present to assist. Intravenous midolazam will be available and administered if 
necessary to make the patient more comfortable and less anxious. Full aseptic precautions will be taken 
with personal protective equipment and bactericidal preparation with chlorhexidine. An ultrasound 
probe will be placed lateral to the patient's upper back and the ideal location of medication injection will 
be identified on an ultrasound image (which is superficial to the transverse processes of the thoracic 
vertebral bodies and deep to the erector spinae muscle). The skin will be made numb with lidocaine 
prior to insertion of a larger needle (Tuohy needle); the proceduralist will direct the Tuohy needle to the 
desired target under ultrasound guidance and the study medication will be delivered through that 
needle (either 25 cc saline or 25 cc 0.5% ropivacaine). A continuous nerve catheter will then be inserted 
through the Tuohy needle to allow for delivery of medication after the study data is collected. The 
Tuohy needle will be removed and the nerve catheter will be secured in place with adhesive dressing. 
After the procedure is performed, continuous vital sign monitoring will occur over 15 minutes, which is 
the standard of care after completion of a nerve block procedure. To reduce confounders, the 
participant will not be permitted to receive oral or intravenous pain medication for 45 minutes after the 
nerve block is performed; this is an alteration of routine care that would be discussed with the patient 
prior to initiation of the study.  
The full effect from a ropivacaine nerve block can take up to 45 minutes and is expected to last a few 
hours. Data measurements will be obtained by the second investigator 45 minutes after the completion 
of the ESP block. For these data measurements, an IS exercise will be performed with the patient is a 
sitting position on the side of the bed, and maximum vital capacity volume will be recorded. Numerical 
pain scores before and after the IS exercise will be recorded.  
Research data collection will be complete at this point and the participant's care will be continued by 
the acute pain service. After the data is collected, the acute pain service and the research participant 
will be updated by the first investigator about which treatment was delivered for the research study. 
The nerve catheter that was inserted will be used for continuation of ropivacaine delivery and will likely 
provide benefit for the participant during their hospitalization.  
 
 
 

The erector spinae plane block and its effect on respiratory status and pain management in rib 
fracture patients 
NCT number:  not available 
Date of document:  January 11, 2019 
 
 
4
STATISTICAL ANALYSIS AND JUSTIFICATION OF SAMPLE SIZE  
Based on three patients at our institution where ESP blocks were performed, incentive spirometry 
values before the block were 500cc, 750cc, and 1000cc; after the block, the values were 1500cc, 1200cc, 
and 2000cc, respectively.  
Using these numbers, based on the equation in An Intro to Medical Statistics (Bland, 2015) and an online 
statistical calculator (http://clinicalc.com/stats/samplesize.aspx), the sample size needed to produce an 
alpha of 0.05 and beta of 0.2 was only 2 participants.  
We believe that for clinical justification of our findings, 2 participants are not adequate. 20 participants 
would make our findings more relevant and likely to encourage a change in practice at other 
institutions. Therefore, we will aim to recruit 24 participants to account for a 20% dropout rate.  
Statistical significance in the primary outcomes will be determined with a paired sample t-test, since 
change will be assessed using paired observations on the same subject before and after an ESP block is 
performed.