Clinical trial NCT02623803
Conditions: Pancreatectomy
Sponsor: Mayo Clinic
Start date: 2016-01-01; Completion date: 2018-02-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.

Detailed description:

Arms: arm 1: lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. arm 2: placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.
Interventions: intervention 1: Lidocaine intervention 2: Placebo D5W
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
 
 
Perioperative Intravenous 
Lidocaine Infusion for Patients 
Undergoing Laparoscopic and 
Open Pancreatectomies 
 
NCT# 02623803 
 
March 30, 2016 


 Research Protocol Submission Template 
 
Title of the study: Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open 
Pancreatectomies 
 
 
Principal investigator:  
Elird Bojaxhi, M.D. 
 
Co-investigator(s):         
Horacio Asbun, J. M.D. 
John Stauffer M.D. 
Klaus Torp, MD       
Ilana Logvinov, DNP, RN 
Sher-Lu Pai, M.D. 
Sorin Brull, MD 
Study coordinator(s): 
Karina Hex, B.S. 
Mauricia Buchanan, RN. 
 
 
 
Protocol version / date 
Version 3. March 30, 2016 
 
Abstract 
DESCRIPTION:   
Patients undergoing major intra-abdominal surgeries, such as pancreatectomies, face the challenge of 
postoperative pain control, return of bowel function, and postoperative ileus. Epidural analgesia offers 
benefits in these areas; however, it is utilized rarely at our institution, because it is an invasive 
procedure with risks and potential complications. 
 
Several studies have demonstrated improved patient rehabilitation after abdominal surgery in which 
patients received perioperative intravenous (IV) infusion of lidocaine. As an adjunct to multimodal 
analgesia, IV lidocaine infusion in colectomy patients has been shown to decrease postoperative pain, 
opioid consumption, postoperative ileus, and length of hospital stay. The purpose of this study is to 
evaluate if an IV lidocaine infusion will provide clinical benefits to pancreatectomy patients with regard 
to analgesia and return of bowel function. 
 
Different titrations of the IV lidocaine infusion for postoperative analgesia have been reported without 
side effects of local anesthetic toxicity (8).   
 
Research Plan 
 
1. Specific Aims 
 
The objective of this study is to see if perioperative IV lidocaine infusion improves postoperative 
analgesia and return to bowel function in patients undergoing open and laparoscopic 
pancreatectomies. If analgesia is improved and return of bowel function is expedited in this patient 
population, then a standardization of practice will be implemented to improve patient outcomes and 
reduce hospital length of stay. 


 
2. Background and Significance  
 
The analgesic properties of local anesthetics have been well documented in the literature (1, 2). 
Proposed mechanism for systemic analgesia include antinociceptive effects by blocking sodium and 
potassium channels, pain modulation in the CNS by inhibiting NMDA and NK receptors, and 
antiinflammatory properties (17).   Intravenous infusions of lidocaine have been used in several types 
of surgeries, including orthopedic, breast, abdominal, and gynecological surgeries. Intra-abdominal 
surgeries involving bowel resection have shown the most favorable outcomes in improved analgesia 
and improved rate of return of bowel function (3, 4, 5). Significant evidence also demonstrates that 
epidural analgesia helps with pain control and return of bowel function in patients undergoing a 
variety of open and laparoscopic intraabdominal cases (6, 7). However, routine use of epidural 
analgesia is implemented infrequently due to an epidural being an invasive procedure with its own 
associated risks and complications. Based on this known information, an intravenous lidocaine infusion 
protocol is being proposed to assess post-operative pain control and improved return to bowel 
function in patients undergoing open and laparoscopic pancreatectomies.  
 
3. Progress Report and Preliminary Studies 
 
Lidocaine infusion during pancreatic surgery, to date, has not been studied. A few trials in cooperation 
with Dr. Asbun have taken place, since January 2015., the patients demonstrated subjectively 
improved pain control in the recovery room and decreased opioid consumption. Plasma lidocaine 
levels measured in 8 patients averaged 2.26 ug/ml (range 1.2 – 3.3 ug/ml), and they were consistently 
below toxic levels and no side effects were noted nor reported by the patient. 
 
4. Research Design and Methods 
 
Study Design or Overview –  
 
50 patients will be recruited in the study. Prior to the day of surgery, all patients are seen by their 
surgeon for their pre-surgical evaluation. At the time, the patient will be consented to participate in 
the study involving lidocaine infusion to improve post-operative pain and control and return of bowel 
function.  
 
As is current practice at or institution for intra-abdominal cases including pancreatectomy surgery, an 
Enhanced Recovery Pathway (ERP) will be utilized as outlined below: 
 
Pre-operative multimodal non-opioid analgesics (single dose P.O. with water): 
• 
Celecoxib 400 mg  
• 
Gabapentin 600 mg  
• 
Acetaminophen 1000 mg  
         
Intraoperative management: 
• 
Maintenance of general anesthesia will be standardized to sevoflurane with air/oxygen  
mixture at 2 L/min 


• 
Fentanyl will be the only opioid use at induction of anesthesia and during the surgery. 
• 
Fluid administration goals – (modified as clinical circumstances dictate) 
o 500 mL per hour for laparoscopic cases 
o 800 mL per hour for open cases 
o Phenylephrine or ephedrine boluses as needed to maintain mean arterial pressure 
(MAP) > 60 mmHg 
• 
Postoperative nausea and vomiting (PONV) prophylaxis 
o Dexamethasone 4 mg I.V. at anesthesia induction (one dose) 
o Ondansetron 4 mg I.V. 30 minutes before emergence from anesthesia (one dose) 
o For patients with a history of PONV, droperidol 0.625 mg I.V. or promethazine 12.5 mg 
I.V. will be given as a third anti-emetic agent. 
• 
Nasogastric (NG) or Orogastric (OG) tube is to be removed at the end of the case unless 
specified by the surgical team. 
 
Postoperative non-opioid analgesics: 
• 
Acetaminophen 1000 mg PO every 6 hours 
• 
Ketorolac 30 mg IV every 6 hours to start after the surgery (total of 4 doses) 
 For patients >65 years old or <50 kg use 15 mg of ketorolac IV 
• 
Ibuprofen 800 mg PO every 6 hours after the last ketorolac dose 
 For patients >65 years old or <50 kg use 400 mg of ibuprofen PO 
 
Opioid analgesia 
• 
Patient Controlled Analgesia (PCA) with IV hydromorphone will be utilized in the first 24 
hours  
• 
IV or PO hydromorphone will be used for breakthrough pain  
 
Diet: 
• Soft, low residue diet evening of POD #0 
• Advance to low fat diet excluding raw vegetables and fresh fruit at 0700 on postoperative day 1 
if patient without nausea. 
• If patient is diabetic, advance to diabetic diet excluding raw vegetables and fresh fruit at 0700 
on postoperative day 1 if patient without nausea. 
 
Activity: 
• Out of bed greater than 1 hour, including 1 or more walks and sitting in chair within 2 hours of 
reaching the surgical floor 
• Day after surgery and until discharge, out of bed greater than 6 hours, including 4 or more 
walks and sitting in chair 
• All meals out of bed 
 
 
 
Intraoperative lidocaine infusion protocol 
 
 
On the day of surgery, the patient will be randomly assigned to either the lidocaine 
infusion (2 grams of lidocaine in 500cc D5W) study group (n=25 patients) or the control group (n=25 
patients) who will receive 500cc of D5W infusion with no lidocaine.  Pharmacy will handle 
randomization of patients. The patient, the surgeon, the anesthesiologist and the postoperative 


nursing staff will be blinded to which group patients were assigned. The infusion bag will be dispensed 
by pharmacy based on the randomization protocol and labeled “Lidocaine Infusion Study” with the 
corresponding IRB number.  
 
 
The anesthesiologists assigned to the case will begin with a bolus infusion of lidocaine, 
1.5 mg/kg (max 100 mg of lidocaine) at the time of anesthesia induction, followed by a continuous 
infusion set at 1.5 mg/kg/hour form the IV bag labeled “Lidocaine Infusion Study” 
 
 
Actual body weight will be utilized in the dosing of lidocaine with a limit of 100mg of 
lidocaine bolused and maximum infusion rate not to excide 3mg/min. Patients with BMI >40 are 
excluded from the study. 
 
 
Intraoperative opioids will be limited to fentanyl in order to standardize intraoperative 
opioid requirements and intraoperative ketamine will be avoided. The surgical team is instructed not 
to infiltrate the surgical wound with local anesthetic during or at the end of surgery. The lidocaine 
infusion will be continued in the PACU. The nurse in the PACU will be instructed to discontinue the 
infusion when the patient meets PACU discharge criteria. The nurse and the surgical team are 
instructed not to use fentanyl during the postoperative period for analgesia.  Prior to the 
discontinuation of the infusion, every patient will have a lidocaine level drawn before leaving the 
PACU.  
 
Intra-op and PACU stopping rules 
 
• 
If unstable arrhythmias are noted in the OR/PACU, the infusion will be stopped and a 
plasma lidocaine level will be drawn.  
• 
If symptomatic bradycardia and significant hypotension refractory to treatment, 
consider stopping the infusion. 
• 
If significant intra-operative hemorrhage (1 body blood volume), consider stopping the 
infusion.  
• 
If the patient requires ICU admission after surgery due to intraoperative complications, 
the infusion will be stopped at the end of surgery. 
• 
If the patient in the PACU demonstrates sudden changes in mental status, convulsion, or 
coma, the infusion will be stopped and a lidocaine level will be drawn. 
• 
If mortality or major complications were to occur during the study, the cases will be 
reviewed by the primary investigator and co-investigators to determine the cause and if poor 
outcome is related to the study. All such cases will also be reported to IRB. 
 
Baseline Assessments 
 
1. 
Pain at rest and with coughing via a Numerical Rating Scale (NRS) – completed on the 
day of surgery in preop holding area 
2. 
Quality of Recovery (QoR-15) questionnaire – completed at the time of consenting or 
preop on the day of surgery. 
Assessment and management in the PACU (day of surgery) 
 
1. 
Pain scores via a Numerical Rating Scale (NRS) will be assessed in the PACU at rest and 
with coughing at the time of PACU arrival and at 30 minute intervals (Appendix A). (15)  If the 


patient is too somnolent upon arrival in the PACU and unable to participate, then the findings 
are to be documented as such (i.e., unable to participate).  
2. 
Upon arrival to PACU and at 30 minutes, patient’s level of consciousness will be 
assessed via the Richmond Agitation-Sedation Scale (RASS) (Appendix B). 
3. 
Upon arrival to PACU and at 30 minute intervals the patient will also be evaluated by the 
PONV Impact Score (Appendix C). 
4. 
Fentanyl use will be avoided in the PACU. 
5. 
Total opioid requirements in the PACU will be noted. Converted to morphine 
equivalents as per Table 1. 
6. 
Use of ketorolac or acetaminophen will be noted 
7. 
Incidence of nausea/vomiting and administered treatment in PACU will be noted. 
8. 
PACU length of stay (defined as the time from PACU admission until discharge criteria 
are meet as per PACU nurse evaluation and documentation). 
9. 
At time of the patient meeting discharge criteria in the PACU, lidocaine infusion will be 
stopped and lidocaine plasma levels will be drawn in all patients in order to keep the PACU staff 
blinded. 
 
Assessment of the patient on the floor 
 
1. 
The patient will be assessed by floor nurse on POD #0 at 8 PM and POD #1 at 8 AM and 
8PM. 
2. 
Pain will be assessed via the NRS scale at the prescribed times at rest and with coughing. 
Nurses will also rate the patients’ average pain on a scale from 0 to 10 (0=no pain; 10=worst 
pain ever experienced) in the past 12 hours, or since their time of surgery if it is POD #0.  
3. 
The current level of consciousness will be evaluated using the RASS score. 
4. 
At 24 hours from the time of arrival to PACU, the patient’s quality of recovery will be 
evaluated by the one of the study coordinators via a validated 15-question Quality of Recovery 
(QoR – 15) questionnaire. 
5. 
At 24 hours from the time of arrival to PACU, the score on PONV Impact Scale will be 
obtained. 
6. 
Need for nasogastric (NG) tube during hospital stay will be noted. 
 
Return of bowel function 
 
During the patients hospital stay, the time to first flatus and first bowel movement will be noted as per 
progress note of the surgical team. The surgical team is specifically instructed to ascertain these 
recovery milestones every morning during clinical rounds.  
 
Additional data include 
1. 
Duration of surgery (in minutes) 
2. 
Time when PACU discharge criteria are met (in minutes) 
3. 
Length of hospital stay 
4. 
QoR-15 questionnaire via telephone call 2 to 3 weeks from the day of surgery. 
 
 
 
b.  Study Subjects.  
 
 


 
Inclusion criteria:   
 
• 
All adult patients undergoing elective open or laparoscopic total pancreatectomies and 
pancreatoduodenectomies (i.e., Whipple procedure), and participating in the ERP. 
• 
Age 18 – 80 years old 
• 
ASA class I – III 
• 
BMI < 40 
• 
Ability to understand and read English 
 
 
Exclusion criteria:  
• 
Not able or willing to sign consent 
• 
Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics 
(i.e., lidocaine). 
• 
History of epilepsy or currently receiving treatment for seizures 
• 
Severe hepatic insufficiency (Child-Pugh Score C) – if documented in patient’s medical 
history 
• 
Renal insufficiency  (creatinine clearance less than 30 mL/minute) – if documented in 
patient’s medical history 
• 
Advance heart failure  
o NY Heart failure stage 3 or greater 
o Ejection function <30% 
• 
Cardiac arrhythmias: 
o 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, 
Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome 
o Left bundle branch block or bifascicular block 
o Not to exclude patients the following conditions unless clinical circumstance dictate:  
 Atrial fibrillation or atrial fluter 
 Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers 
• 
Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, 
sotalol, etc.) 
o Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical 
circumstance dictate 
• 
Patients with active psychiatric disorders (such as schizophrenia, bipolar disorder) or 
cognitive dysfunction 
• 
Pregnancy or lactating 
• 
Enucleation, central, and distal pancreatectomy 
• 
Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day) 
 
Sample Size – The study will include 50 patients to be randomized and blinded in two groups of 25 
patients each. No prior studies have been conducted on patients undergoing pancreatectomies and 
receiving a lidocaine infusion. However, several studies have shown statistical significant improvement 
in postoperative pain control and reduction of opioid requirement with the use of lidocaine infusion for 
intraabdominal surgeries, and often requiring 20 to 50 patients. (8) Additional 7 subjects will be 
screened to reach target accrual of 50 patients. 
  
Data Collection –  


 
Preoperative 
 
1. 
Age, Sex, ASA Physical Status, Height, Weight, and BMI 
2. 
Analgesics including opioids, NSAIDs, and/or acetaminophen (as per home medication 
list) 
3. 
Current pain score as per NRS scale 
4. 
QoR - 15 
 
Intraoperative 
 
1. 
Total pancreatectomies or pancreatoduodenectomies (as per post-op surgical note) 
2. 
Open or laparoscopic (note if the case was converted to open) 
3. 
Surgeon 1 or 2 (Drs. Asbun or Stauffer) 
4. 
Duration of surgery 
5. 
Duration of lidocaine infusion (time from induction to discontinuation in the PACU) 
6. 
Total amount of fentanyl used in the OR. 
7. 
Amount of anesthetic gas used (sevoflurane at 2L/min of fresh gas flow) 
i. At the conclusion of the surgery, the anesthetic gas consumption will be as recorded 
by our Apollo Anesthesia Machine – Dräger 
ii. Hourly vapor anesthetic requirements will be determined by the total anesthetic 
gas used divided by duration of the case (intubation time to surgery end time) 
 
PACU 
 
1. 
Pain score on arrival to PACU and at 30 minutes at rest and with coughing using the NRS 
scale 
2. 
RASS score on arrival to PACU and 30 minutes after PACU admission 
3. 
Incidence of PONV as reported and treated by PACU nurse. 
4. 
Opioid requirements as converted into morphine equivalents (Table 1) 
5. 
Use of acetaminophen or NSAIDs 
6. 
Total PACU time (arrival to PACU until meeting discharge criteria as per PACU nurse)  
7. 
Time of the discontinuation of the infusion 
8. 
Plasma lidocaine level at the discontinuation of the infusion 
 
 
Table 1: Morphine-equivalent based on an opioid equianalgesic 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Postoperative day 0 -1 
 
1. 
POD #0 at 8PM and POD #1 at 8AM and 8PM: 
a. Current pain via NRS scale at rest, coughing, and average of the past 12 hours or since 
surgery if POD #1  
b. Current RASS score 
2. 
At 24 hours from arrival to PACU 
a. Quality of Recovery (QoR – 15) questionnaire with assistance of a co-investigator (16). 
b. Opioid requirements as converted into morphine equivalents 
c. Acetaminophen or NSAIDs use 
 
Hospital stay 
 
1. 
First time to flatus (in days) 
2. 
First time to bowel movement (in days) 
3. 
Presence of NG tube (in days) 
4. 
Length of hospital stay (in days) 
 
Outpatient follow up 
 
1. 
QoR – 15 via telephone call 
 
Data Handling – Data will be entered into a secure REDCAp database by study assistant. Principal 
Investigator will verify data to ensure accuracy.  
 
Data Analysis -  A t-test will be used to analyze mean differences in NRS scores, opioids requirements, 
and return of bowel function between groups. Complication rates will be analyzed using a Chi-squared 
analysis. 
 
Feasibility and Time Frame – About 100 pancreatectomies per year are done at out institution. 
Anticipating that 50% of patients are not enrolled due to the exclusion criteria or unwillingness to 
Opioid Drug 
(mg) 
Administered 
equianalgesic ratio to oral 
morphine 
Morphine 
PO 
1:1 
Morphine 
IV 
3:1 
Oxycodone 
PO 
1.5:1 
Hydrocodone 
PO 
1:1 
Fentanyl 
IV 
300:1 
Fentanyl 
Transdermal 
70:1 
Oxymorphone 
PO 
3:1 
Oxymorphone 
IV 
30:1 
Hydromorphone IV 
18:1 
Hydromorphone PO 
4:1 
Tramadol 
PO 
0.3:1 


participate in the study, the anticipated time frame of patient recruitment for this study will be one 
year. 
 
Strengths – The study focuses on a patient population that frequently has difficulties with 
postoperative pain control, delayed return of bowel function and ileus, which are often exacerbated by 
opioids. This study will determine if incorporating lidocaine infusions will be of help to this patient 
population. Also, the proposed study has been previously performed on similar surgical procedures 
with demonstrating improved postoperative analgesia and without any adverse outcomes (8, 9, 10). All 
drugs and personnel required for this study are readily available and in place at Mayo Clinic. 
 
Limitations – Even though highly unlikely, the potential for local anesthetic toxicity exists. During the 
patients’ intraoperative course, EKG, blood pressure, and pulse oximeter will be closely monitored for 
any potential signs of arrhythmias. If there is any suspicion of local anesthetic toxicity, the infusion will 
immediately be discontinued, the anesthesiologist taking care of the patient will be unblinded, and a 
serum level of lidocaine will be drawn at that time if appropriate. Close monitoring of the patients will 
also continue to take place in the PACU, as is the standard of care.  
 
 
5. Human Subjects 
Detailed Description: All human subjects will meet the criteria aforementioned and will be 
undergoing open or laparoscopic total and subtotal pancreatectomies.  
Population:  Patients who are scheduled to undergo either open or laparoscopic pancreatectomy 
will be given the opportunity to provide an informed consent for this study. Patients will be 
selected without regard to race or gender. We plan to enroll 50 patients who will meet inclusion 
and exclusion criteria.  
Research Materials: Data elements will be obtained from the patients’ medical record and entered 
into REDCap database  
Recruitment of Subjects: Patients will be recruited at the surgeon’s office, during their pre-
operative visit. The prospective candidates for the study will be approached by the study team 
member. Patients will be given information regarding the drug, the potential benefits, and 
complications of being enrolled in the study. Patients will be given adequate time to review the 
consent form, ask questions, and make an informed decision to either participate or decline. 
Potential Risks: Even though highly unlikely, the potential for unknown local anesthetic toxicity 
exists. Early or mild sign and symptoms of toxicity include sudden dizziness, confusion, tinnitus, 
metallic taste, and numbness or tingling of fingers, toes, or lips. These signs and symptoms may 
progress to convulsions, unconsciousness, sudden hemodynamic instability, cardiac arrhythmias, or 
cardiac arrest. To date, there are no documented cases of morbidity or mortality associated with IV 
lidocaine analgesia. 
Every participant in this study will be closely monitored by the anesthesia providers. During their 
intraoperative course and in the PACU, EKG, blood pressure and pulse oximeter will be closely 
monitored for any potential signs of arrhythmias. If there is any suspicion of local anesthetic 
toxicity, then the infusion will immediately be discontinued and a serum level of lidocaine will be 
drawn at that time. The study team members will become unblinded to determine the relatedness 
of side effects to the study drug.  


Protection:  The patient will be enrolled into a randomization table and a number will be assigned 
to them. The randomization assignments will be handled through REDCap database by a research 
pharmacist. Only study team members will have access to this project in the database. All study-
related regulatory documents will be stored electronically on the Department of Anesthesia 
research drive. The access to this research folder is limited to study team members and information 
backed up by Mayo Clinic’s IT department to secured servers. 
Benefits:  Patients undergoing pancreatectomies often have decreased bowel function, difficult to 
control post-operative pain, and prolonged hospital stays. The study focuses to reduce these 
factors and improve patient outcome. The potential risks are minimal to none. Numerous previous 
studies have not demonstrated adverse outcomes to the patients. 
 
6. Gender/Minority Mix 
 
We plan to enroll the 50 patients regardless of race or gender. The exclusion will be made as previously 
described in Research Design and Methods section. Women of childbearing potential will be included 
in this study provided that they had a negative pregnancy test performed as part of their routine 
preoperative work-up. 
 
7. References: (Limit to one page) 
 
1) DeClive-Lowe SG, Desmond J, North J. Intravenous lidocaine anaesthesia. Anaesthesia 
1958;13:138-46.  
2) Bartlett EE, Hutaserani 0.Xylocaine for the relief of postop- erative pain. Anesth Analg 
1961;40:296-304.  
3) Holte K, Kehlet H: Postoperative ileus: A preventable event. Br J Surg 2000; 87:1480–93 . 
4) Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML et al. Intravenous lidocaine 
infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology 2007; 106: 
11–18.  
5) Wallin G, Cassuto J, Hogstrom S, Linden I, Faxen A, Rimback G et al. Effects of lidocaine infusion 
on the sympathetic response to abdominal surgery. Anesth Analg 1987; 66: 1008 – 1013.  
6) Wheatley RG, Schug SA, Watson D: Safety and efficacy of postoperative epidural analgesia. Br J 
Anaesth 2001; 87:47–61 . 
7) Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW: Randomized clinical trial comparing 
epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. 
Br J Surg 2003; 90:1195–9  
8) Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and 
postoperative recovery after abdominal  
9) Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H et al. Systemic 


lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, 
randomized, placebo-controlled trial.Ann Surg 2007; 246: 192–200.  
10) Rimback G, Cassuto J, Tollesson PO. Treatment of postoperative paralytic ileus by intravenous 
lidocaine infusion. Anesth Analg 1990; 70: 414 – 419.  
11) McCaffery, M., Beebe, A., et al. (1989). Pain: Clinical manual for nursing practice, Mosby St. 
Louis, MO 
12)  Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, 
Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time 
in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 
2003 Jun 11;289(22):2983-91 
13) Myles PS, Wengritzky R,  Simplified postoperative nausea and vomiting impact scale for audit 
and post-discharge review. Br. J. Anaesth. (2012) 108 (3): 423-429. 
14) Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative 
quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. 
15) Hjermstad MJ, Fayers PM, Haugen DF,. Studies Comparing Numerical Rating Scales, Verbal 
Rating Scales, and Visual Analogue Scales for Assessment of Pain Intensity in Adults: A 
Systematic Literature Review. Journal of Pain and Symptom Management. 2011 June; 41(6): 
1073 – 93 
16) Gower ST1, Quigg CA, Hunt JO, Wallace SK, Myles PS. A comparison of patient self-administered 
and investigator-administered measurement of quality of recovery using the QoR-40. Anaesth 
Intensive Care. 2006 Oct;34(5):634-8. 
17) Hollmann MW, Durieux ME. Local Anesthetics and the Inflammatory Response: A New 
Therapeutic Indication? Anesthesiology. 2000;93(3):858-875 
 
8. Other: 
 
Budget:  The proposed budget will include the costs associated with:  
 
1) Laboratory tests for plasma lidocaine levels (one per each enrolled subject) 
$17.50 x 50 = $875 
2) Lidocaine infusion bags (2g/500cc D5W) for 25 patients 
$8.55 + $1.90 + $55 = $65.45 x 25 = $1636.25 
3) 500 cc D5W infusion bag 
$6.73 + $1.90 + $55 = $63.63 x 25 = $1590.75 
4) Initial pharmacy fee (one time) 
$1700 
5) Total budget for one year: $5,802 
6) Total budget including 30% indirect rate: $7,542.60 


9. Appendix  
 
Appendix A – Pain Assessed via the Numerical Rating Scale (NRS) (11) 
 
 
 
The patient is asked to rate their current pain on a scale from 0 (no pain) to 10 (worst pain imaginable) 
at rest and with coughing.  
 


Appendix B – Richmond Agitation-Sedation Scale (12) 
 
Score Classification  Description 
4 
Combative 
Overly combative, violent, immediate danger to staff 
3 
Very agitated Pulls or removes tube(s) or catheter(s); aggressive 
2 
Agitated 
Frequent nonpurposeful movements; fights ventilator 
1 
Restless 
Anxious but movements not aggressive or vigorous 
0 
Alert and 
Calm 
 
-1 
Drowsy 
Not fully alert, but has sustained awakening to voice (eye opening/eye contact 
>10 seconds) 
-2 
Light 
Sedation 
Briefly awakens with eye contact to voice (< 10 seconds) 
-3 
Moderate 
Sedation 
Movement or eye opening to voice but no eye contact 
-4 
Deep 
Sedation 
No response to voice, but movement or eye opening to physical stimulation 
-5 
Unarousable 
No response to voice or physical stimulation 
 
 


Appendix C – The PONV Impact Scale (13) 
 
 
 
 


Appendix D – Quality of Recovery (QoR – 15) Questionnaire (14)