A DOUBLE-BLIND RANDOMIZED TRIAL ASSESSING THE ASSOCIATION BETWEEN TYPE OF LOCAL ANESTHESIA TREATMENT AND POSTOPERATIVE PAIN IN PATIENTS IN HAVING UNDERGONE ARRHYTHMIA SURGERY
Phase: NA
Conditions: Post-operative Pain
Sponsor: Baylor Research Institute

Study Procedure IRB #: 008-197  
 
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Study Protocol & Procedures: 
Local Anesthetic / Post-operative Pain Trial 
IRB #: 008-197 
 
 
 
 
Contacts: 
 
On-Site Study Coordinators: 
Ja-Karsha Culton, Jing Wang, Katherine (Blair) Kerwin, Poupak Moshayedi 
Phone: 214.820.2273 
Email: JaKarsC@BaylorHealth.edu  
            Jing.Wang@BaylorHealth.edu  
 
Katherine.Kerwin@BaylorHealth.edu 
 
Poupak.Moshayedi@BaylorHealth.edu 
 
Research Coordinator: 
Teresa Phan, MS, MS 
Phone: 214.265.3632 
Email: Teresa.phan@baylorhealth.edu  
 
Co-PIs: 
 
Udaya Padakandla, MD 
Phone: 214.564.3225 
Email: UdayaP@BaylorHealth.edu 
 
Giovanni Filardo, MPH, PhD 
Phone: 214.265.3633 
Email: GiovanFi@BaylorHealth.edu 
 

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Protocol 
1Background: Patients receiving a new pacemaker or defibrillator are currently given 
Bupivacaine, Lidocaine, or a mixture of the two for local anesthetic treatment (in addition 
to general anesthesia).  The choice of local anesthetic to be used during surgery is based 
primarily on the differences in time for the anesthetic to take effect and duration 
thereafter.  Lidocaine typically works in less than 1 minute and lasts approximately 45 
minutes.  Bupivacaine works within 2 to 3 minutes and lasts 4 to 6 hours.  Lidocaine is 
often preferable due to its shorter time of effectiveness.  However, its relatively short 
duration may translate into a higher use of intravenous (IV) narcotics for pain 
management during postoperative care – particularly within the first hour following 
emergence from general anesthesia.  Therefore it is conceivable that these patients would 
have higher levels of pain as well as higher cost of care related to cost of narcotics and 
caregiver time required to administer them.   
 
2Objectives: The goal of the proposed study is to investigate the relationships between 
treatment with lidocaine or a mixture of lidocaine and Bupivacaine and pain, consequent 
narcotic treatment, and patient movement during anesthesia while adjusting for other 
clinical and/or demographic factors in consecutive subjects who undergo arrhythmia 
surgery at Baylor Heart and Vascular Institute over several months.    
 
3This study will focus primarily on assessing the relationship between local anesthetic 
choice and postoperative pain for patients who receive a new pacemaker or defibrillator. 
The primary outcome of interest is: pain as measured by a standardized and validated 
scale, the Visual Analog Scale (VAS) at 3 time points: prior to surgery, once awakened 
from surgery, 4 hours after, and 4-24 hours after.  The secondary outcomes of interest 
are: IV narcotic use (including dosages and strength of narcotic) within 1 hour after the 
patient emerges from general anesthesia and patient movement during the insertion of 
pacemaker or defibrillator.  Data source: All data for the proposed investigation will be 
abstracted from the patient charts included in the study cohort.   
 
4Study Design: The proposed investigation is a randomized trial comparing the efficacy 
of two standard local anesthetic treatments in terms of postoperative pain and narcotic 
use following pacemaker or defibrillator insertion.  Standard local anesthetic choice will 
be classified as Lidocaine (a standardized dose of 10 cc 1% solution) or a combination of 
Bupivacaine and Lidocaine (a standardized dose of 6 cc 1% Lidocaine mixed with 4 cc 
0.25% Bupivacaine solution).  Both solutions are clear with a total volume of 10 cc.  The 
BHVH pharmacy will draw up the appropriate treatment, rendering the surgeon 
administering the local anesthetic blinded to the identity of the local anesthetic.  Volume 
administered as well as other clinical and demographic data will be obtained for each 
patient.  Pain will be measured using the VAS (a standardized and validated scale) at 3 
time points: prior to surgery, once awakened from surgery, 4 hours after, and 4-24 hours 
after. The type, number, and dose of narcotics will be collected up to 24 hours after 
patient awakens from surgery.  The study cohort will comprise all consenting patients 
who undergo new pacemaker or defibrillator insertion and consent to have data collected 
regarding the insertion of a pacemaker/defibrillator device at Baylor Heart and Vascular 

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(Dallas, TX) between 11/03/2008 and 08/30/2012, approximately 350 patients. 
Additional Study Procedures are attached after the protocol.  
 
  
5Inclusion Criteria: Patients consenting to routine data collection in Apollo at Baylor 
Jack and Jane Hamilton Heart and Vascular Hospital, at least 18 years of age, and 
receiving only: ICD implant, single chambered pacemaker implant, or dual chambered 
pacemaker implant, for whom either Lidocaine or Bupivacaine is not contraindicated.   
 
6Exclusion Criteria: Patients not consenting to routine data collection in Apollo at 
Baylor Jack and Jane Hamilton Heart and Vascular Hospital; and/or under 18 years of 
age; and/or receiving procedures other than: ICD implant, single chambered pacemaker 
implant, or dual chambered pacemaker implant; and/or Lidocaine or Bupivacaine is 
contraindicated.  
 
7Risks: Risks incurred as a result of administering lidocaine or lidocaine / Bupivacaine 
mixtures for this study will be no different than the risks incurred via administration of 
either treatment as a result of standard care in pacemaker / defibrillator insertion.  These 
risks include: CNS depression, CNS excitement, cardiac arrhythmias, allergic reaction, 
and trouble breathing (allergic reaction, low blood pressure, difficulty breathing, fast 
heart rate, slow heart rate, feeling light headed, tremors, seizure, chest pain, weak pulse, 
nausea, vomiting, anxiety, speech problems and headache). 
 
8Potential Benefits: It is possible that one treatment may result in diminished pain post-
surgery. This would result in diminished pain for those participants assigned to that 
specific treatment group. This research may benefit individuals in society by revealing a 
more cost effective treatment with less pain incurred after implementation of 
pacemaker/defibrillator devices.  
 
9Risk to Benefit Analysis: Patients receiving a pacemaker or defibrillator are currently 
given Bupivacaine, Lidocaine, or a mixture of the two for local anesthetic treatment (in 
addition to general anesthesia).  The choice of local anesthetic to be used during surgery 
is based primarily on the differences in time for the anesthetic to take effect and duration 
thereafter.  Lidocaine typically works in less than 1 minute and lasts approximately 45 
minutes.  Bupivacaine works within 2 to 3 minutes and lasts 4 to 6 hours.  Lidocaine is 
often preferable due to its shorter time of effectiveness.  However, its relatively short 
duration may translate into a higher use of narcotics for pain management during 
postoperative care – particularly within the first hour following emergence from general 
anesthesia.  Therefore it is conceivable that these patients would have higher levels of 
pain, higher cost of care related to cost of narcotics, and higher cost of caregiver time 
required to administer them.  Either treatment is standard for these procedures, so no 
additional risk will be incurred by assigning treatment to either Lidocaine or 
Bupivacaine/Lidocaine mixture. 
 
 

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10Payment/ Compensation/ Subject Costs: The research subjects will not receive a 
stipend for participation in the study.  There will be no cost to the subjects.  
 
Confidentiality  
 
11Data Storage: An appropriate database will be created and managed in 
compliance with HIPAA regulations.  Data will be stored safely in a secure environment, 
and maintenance for back-up purposes will be performed on a routine basis. 
 
12Research Subject Privacy: Patients will be approached discretely and privately 
by the study coordinator on location at Baylor Heart and Vascular Hospital prior to their 
procedure.  The discretion of the study coordinator will be used to judge if privacy (from 
both medical personnel and other persons in the hospital) is ensured during the consent 
process.  The patient will be informed that they can stop the consent process at anytime if 
they feel their privacy is being compromised.  No information will be collected directly 
from the patient after this point.  Patient will be informed that participating / not 
participating in this study will in no way affect their care and that they are in no way 
obligated or expected to participate.  If the patient agrees to participate, they will be taken 
through the informed consent process.  Upon data acquisition, study identifiers will be 
encrypted to protect patients’ privacy and meet HIPAA regulations, and data will be stored 
in a secured database while periodic back-up will protect against catastrophic data loss.  
All hard copy material (summary printouts) will be stored by the principal investigator in 
locked file cabinets and the disks, diskettes, and other removable storage media files will 
be safely stored as per HIPAA regulations.  The ability to decode the study identifier will 
be restricted to the principal investigator. 
 
 
 

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Study Procedures: 
 
Defining potential participants 
Timing: 1 day prior to surgery: 
 
On-Site Study Coordinator: 
 
• On-Site Study Coordinator will access the EP’s schedules via MediTech one day 
prior to surgery.  Those patients receiving any of the following may be considered 
for inclusion in the study: 
 
o BiVD (CRT) 
o ICD 
o Pacemaker 
 
• On-Site Study Coordinator will contact Electrophysiologist to gain permission to 
approach patient. 
 
 
 

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WebEx Login info:  
            Web address:       http://sphinxanesthesia.webexone.com 
 
Login Name:         
 
Login Password:  

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Consent and Randomization 
Timing: Day of surgery – Prior to procedure immediately following consent. 
Location: 4th Floor BHVH. 
 
On-Site Study Coordinator: 
 
• On-Site Study Coordinator will approach patient the day of procedure, prior to 
procedure in patient room to consent patient. 
 
• On-Site Study Coordinator will retain a signed copy of the consent document.  
The study participant will also be provided a copy of the consent document. 
 
• On-Site Study Coordinator will determine randomization assignment of each 
participant the day of procedure after having consented the participant.  
Randomization will occur as follows: 
 
o Within the randomization notebook, the section corresponding to the 
appropriate EP will be selected. 
o Within this section, the appropriate procedure subsection (based upon the 
gender of the participant) will be selected. 
o Within this section, the subsection representing the patient’s procedure 
type will be selected. 
o In first available slot on the procedure type section, the On-Site Study 
Coordinator will enter the patient’s name, MRN and social security 
number in the appropriate location. 
▪ Treatment assignment number will be listed to the right of SSN.   
▪ The treatment assignment number correlates to an envelope with 
the treatment assignment sealed within to be brought to the BHVH 
pharmacy, only to be opened by the pharmacy staff. 
 
• On-Site Study Coordinator will attach a study participation letter onto the 
patient’s chart prior to EP entry into the surgical room. 
 
 
 
 
 
 
 
 
 
 
On-Site Study Coordinator will inform nursing staff of patient enrollment into 
study (on 3rd floor BHVH). 

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Treatment Preparation 
Timing: Day of surgery – Prior to EP entering EP suite. 
Location: 3rd Floor BHVH 
 
EP nursing staff: 
 
• EP nursing staff will look at patient chart to identify if study participation letter is 
present and notify the electrophysiologist. 
 
• EP nursing staff will provide the electrophysiologist with the pre-drawn syringe.  
 
• EP nurse will report “local anesthetic” and dosage in the patient’s chart as per 
usual procedure. 
 

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Surgical Procedure 
Timing:  Day of surgery - During surgical procedure / device implantation 
Location: 3rd floor BHVH 
 
EP Nursing staff: 
 
• Please follow standard protocol for recording/measuring pre-operative pain. 
 
 
      Anesthesiologist: 
 
• You will have no real responsibilities for this trial; however, we do ask that you 
standardize the anesthesia protocol with fentanyl and propofol (using 
anything else such as midazolam, sufentanyl, etomidate, pentothal, ketorolac and 
local anesthetics like mepivacaine could disqualify the patient). 
 
• Dosing should be based on individual patient factors and your judgment. 
 
• If for any reason you must deviate from this protocol, please notify On-Site 
Study Coordinator and/or research coordinator. 
 
 
Surgeon: 
 
• You will administer local anesthetic as given to you by the EP nursing staff. 
 
• If for any reason you are required to give more local anesthetic, you may do so, 
but it is important that the supplemental administration be documented in the 
Apollo report.   
 
• Please notify On-Site Study Coordinator or research coordinator if you are 
required to administer more local anesthetic. 
 
 
 

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Data abstraction and adverse event monitoring 
Timing: Post-surgery 
 
EP Nursing Staff: 
 
• Please follow standard protocol for recording/measuring post-operative pain. 
 
 
On-Site Study Coordinator: 
 
• On-Site Study Coordinator will check EP lab records to determine local anesthetic 
given to patient. 
 
• On-Site Study Coordinator will abstract chart information onto case report form. 
 
• Adverse events will be determined from patient charts and reported within 7 days. 
 
• All forms will be forwarded to the research coordinator. 

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Treatment verification and continued monitoring 
Timing: Post-surgery (daily): 
 
Research coordinator: 
 
• Research coordinator will verify randomization number received correct study 
medication. 
 
• BHVH data will be queried to verify all patients are discharged post-surgery 
(disposition type, disposition date, and discharge date will be queried).  If they are 
not discharged this may constitute serious adverse event (SAE) and research nurse 
or coordinator will report to IRB immediately (within 24 hours).