Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)
Phase: PHASE4
Conditions: Thoracic Surgical Procedures
Sponsor: Charles Luke

 
 
 
 
 
 
 
 
 
 
STUDY TITLE: Randomized Clinical Trial of Erector Spinae Plane (ESP) vs. 
Paravertebral Nerve Blockade for Video Assisted Thoracoscopic Surgery (VATS) 
 
IRB ID: PRO18070064 
 
NCT Number: NCT03758261 
 
STUDY PROTOCOL – 08/28/2019 
 
 

ESP vs. PVB Nerve Blocks for Video Assisted Thoracoscopic Surgery (VATS) Research  
Protocol 
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted 
techniques at UPMC for pain management in thoracic surgery. This is a prospective randomized 
study intended to assess the efficacy, safety and side-effect profile of continuous ESP block Vs 
continuous paravertebral block for VATS procedures.  
Methods:  
Once the patient has agreed to have peripheral nerve blocks as part of the analgesia technique and 
meets inclusion criteria, the patient will be asked to participate in the study. If they agree to 
participate, informed consent will be obtained and we will proceed with randomization.  
Patient selection and Inclusion/Exclusion criteria 
Inclusion criteria: 
* Patients undergoing VATS agreeable to have a nerve block as analgesic technique 
* Age: 18 years old and older. 
* ASA I-IV 
Exclusion criteria: 
* Cognitive impairment that would not allow effective nerve block placement or gathering 
information related to the study (ex. pain score). 
* Contraindications for nerve block placement such as coagulopathy, use of clopidogrel in the past 
48hs, patients on dual antiplatelet therapy, infection at the site of puncture, patient refusal, allergy 
to local anesthetics. 
* Chronic opiate consumption (>30 OME/day) 
* Patient expected to be on therapeutic anticoagulation post procedure. 
* Pregnancy 
* Comorbid conditions: Any comorbid condition that in the judgment of the anesthesiologist would 
preclude the patient from any aspect of the study (ex. sepsis, possibly abnormalities of the thoracic 
spine or paravertebral anatomy such as neoplastic mass occupying the space, empyema, increased 
intracranial pressure) 
Randomization: Patients will be randomized 1:1 into one of the study groups. The groups will be 
defined as Group 1: ESP block; Group 2: PVNB.  
The goal is to include 80 patients (40 in each arm). 
Before insertion of catheter, ropivacaine 0.5% will be injected incrementally prior aspiration to 
decrease the risk of intravascular injection every 5ml. The dose will be left at discretion of the 

anesthesiologist performing the nerve block, with a volume that would provide effective 
dermatome coverage and considering the maximum possible dose to avoid local anesthetic 
toxicity. After administration of LA catheter will then be placed and left 5cm beyond the needle 
tip. 
Continuous Infusion: bupivacaine 0.0625% will be started at 6ml/h and will be titrated up to a 
max of 12ml/h. 
Bolus: patients will have access to rescue boluses of 3ml every hour, through the catheter with 
bupivacaine 0.0625% if needed. 
All patients will be assessed daily by the acute pain service. Additional pain medication will be 
available to all patients per standard of care. All patients will have access to acetaminophen 1g 
every 6hs, ketamine infusion, and opiates as needed to provide adequate analgesia. 
 
Data collection 
Preoperative period: 
In addition, to treat breakthrough pain, all patients will receive multimodal analgesia per routine. 
An excel sheet will be available to collect the patient information from EMR and the patient. 
- 
Data to be collected: age, gender, type of surgery, type of anesthesia (including  
medications and type regional anesthesia received). 
- 
Incentive spirometer baseline  measure prior to surgery 
- 
dermatomal spread (pinprick and or changes in temperature (cold or hot) sensation) after 
15-20mins of initial bolus will be documented. 
 
Postoperative period: 
In PACU:  
- 
Intraoperative opiate consumption in (morphine equivalent dose) and while in PACU. 
- 
pain scores using the numeric rating scale. 
- 
insertion site and number of catheters will be documented 
- 
dermatomal spread (pinprick and or changes in temperature (cold or hot) sensation) will be 
documented.  
- 
number of chest tubes and sites 
Postoperative period 
- 
total opioid consumption (in morphine equivalents) and pain scores on the numeric pain 
rating scale will be documented every 6hs for the first 24hs. 
- 
Incentive spirometer daily score postoperatively 
- 
Length of stay,  

- 
Duration of catheter 
- 
Use of  additional pain medication will be recorded 
- 
Document adverse events or complications related to nerve blocks 
- 
dermatome spread with infusion infusion will be documented.