Clinical trial NCT02805504
Conditions: Urinary Tract Diseases
Keywords: Bupivacaine Minimally Invasive Surgical Procedures
Sponsor: Loma Linda University
Start date: 2016-07-11; Completion date: 2022-05-09
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

Detailed description:
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:

The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection

Primary Outcome Measures:

* Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay
* Postoperative pain assessment using visual Analog Pain Scores \& Brief Pain Inventory form.
* Length of Hospital Stay
* Time to First Opioid Use.
* Postoperative Constipation , paralytic ileus

Arms: arm 1: This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. arm 2: This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Interventions: intervention 1: Exparel intervention 2: Marcaine
Intervention descriptions: intervention 1: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. intervention 2: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Title: Eﬃcacy of the liposomal bupivacaine for postopera6ve pain control in urologic procedures 
 
NCT#: NCT02805504 
 
Document Date: 05/11/201 


 
 
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PROTOCOL OUTLINE AND GUIDELINES 
 
Investigators must submit well-organized, detailed information about the study, demonstrating 
sound research design that minimizes risks to the subject.  PI should assure that the content 
outlined below is addressed and may exercise some discretion as to how the information is 
organized.  The quality and content of the protocol should demonstrate that scientific and merit 
review of the study has occurred at the departmental level prior to submission to the IRB. 
  
 
 
1. 
PROTOCOL INFORMATION  
Title: Efficacy of the liposomal bupivacaine for postoperative pain control in urologic 
procedures.  
Phase of Study: Prospective Study.  Phase IV 
 
2. 
PRINCIPAL INVESTIGATOR’S INFORMATION 
PI Name: Dr. D. Duane Baldwin  
Title: Full Time Faculty of Loma Linda University Urology Department.  
Name & Address of Research Institution: Loma Linda University, Urology. 
Department. 11234 Anderson Street Loma Linda, California 92354.  
Phone #: ext: 44196. 
FAX #: 558-4806. 
Email Address: dbaldwin@llu.edu. 
 
3. 
STUDY PERSONNEL 
Duane Baldwin, Andrea Staack, Mohamed Keheila, Jim Shen, Salim Cheriyan, Patrick 
Yang, Nazih Khater (see application for contact info) 
 
4. 
STUDY INFORMATION 
Location(s) of Research Activity: Loma Linda University Medical Center 
Expected Start/Stop Dates of Research: 5-30-2016/5-30-2018  
Special Time Sensitivities: None  
Type of Research: Prospective randomized controlled study using patient information 
from medical records. 
 
5. 
INCLUSION / EXCLUSION CRITERIA 
Inclusion criteria:  
x Males or females 18-years-old or older. 
x Undergoing urologic surgery. 
Exclusion Criteria:  
x Pregnant and/or nursing mothers. 
x Allergy to bupivacaine. 
x History of drug/alcohol abuse 
x Severe cardiovascular, hepatic, renal disease or neurological impairment. 
 
6. 
SUBJECT RECRUITMENT & SCREENING 
Fifty subjects will be recruited for the study with an expected attrition rate of 10%. 
Sample size has been minimized, but is necessary for statistical power and 


 
 
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conclusions. Subjects will be male and female 18 years or older, of all ethnicities, 
denominations or other social/economical variations. All participants will speak 
English fluently in order for consent to be performed properly. Baseline pain score 
will be calculated through a questionnaire in at the urology clinic  
 
Subjects of prospective study will be randomly divided using electronic program into 
two groups:  
 
x The first group will receive intraoperative local Liposomal Bupivacaine 
injection at the port placement site.  
x The control group will receive will local Marcaine (bupivacaine HCl) 
injection 
Primary Outcome Measures: 
x 
Total opioid consumption measured in intravenous morphine equivalents dose 
during the postoperative hospital Stay  
x 
Postoperative pain assessment using   visual Analog Pain Scores & Brief Pain 
Inventory form. 
x 
Length of Hospital Stay 
x 
Time to First Opioid Use. 
x 
Postopreative Constipation , paralytic ileus  
 
Time Frame: All data was recorded during the patient's hospital stay. All data will be 
collected   from the electronic medical record, typically within 30 days of discharge from 
hospital.  
 
 
7. 
INFORMED CONSENT PROCESS 
 
Informed consent will be accomplished and signed at the Urology offices in the 
LLUMC or at the Urology FMO clinic. Consent will be obtained by the research 
coordinator or other trained investigators. Subjects will be randomly assigned as they 
are enrolled using a code system.  
 
8. 
STUDY DESIGN 
Background or rationale for this study: 
 Liposomal bupivacaine was developed to extend the duration of efficacy of 
bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of 
liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized 
controlled trials using liposomal bupivacaine for bunionectomy and 
hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, 
liposomal bupivacaine has also been found to improve pain control for patients 
undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic 
port sites is a common practice that has been shown in some studies to improve 
postoperative pain.  Currently, no standard of care exists for postoperative pain and 
management is based on surgeon and anesthesiologist preferences. Liposomal 
bupivacaine has been one form of administered local, long-acting analgesia that 


 
 
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surgical centers have turned to. In addition, the analgesia has fewer adverse effects 
than opioids, with comparable adverse effects to those seen in bupivacaine alone.  
Objectives: A prospective, randomized controlled study to determine the efficacy of 
liposomal bupivacaine given by local injection at all the wound sites in patients 
undergoing urologic surgeries.  
Procedures involved (Research Interventions):  
x The first group will receive intraoperative local Liposomal Bupivacaine 
injection at the surgical site.  
x The control group will receive and will receive   local Marcaine (bupivacaine 
HCl) injection. 
9. 
DATA COLLECTION 
We will be using electronic medical records to retrieve data from subjects who will 
undergo urologic surgery and save it in s secured excel file. 
 
10. 
LABELING & STORAGE OF DATA & SPECIMENS 
Code linking to subject identifiers will be stored securely on the LLU/LLUMC 
secured server. If research data is to be stored in hard copy format it will be in a 
locked office. Research data will also be primarily stored electronically on the 
LLU/LLUMC secured server. Electronic information will be kept on a secure server 
(department shared drive) and only shared through LLUMC secured email 
 
11. 
DATA ANALYSIS 
We will compare the outcomes by comparing similar surgeries and in patients 
with similar epidemiology characteristics between who will receive liposomal 
bupivacaine     injection to those who will receive (bupivacaine HCl) injection. It 
with focus on the pain related outcomes using SPSS. 
 
12. 
RISK AND INJURY 
The safety of EXPAREL was evaluated in 10 randomized, double-blind, local 
administration into the surgical site clinical studies involving 823 patients undergoing 
various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg 
of EXPAREL. In these studies, the most common adverse reactions (incidence greater than 
or equal to 10%) following EXPAREL administration were nausea, constipation, and 
vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 
10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, 
anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, 
muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain. The less 
common/rare adverse reactions (incidence less than 2%) following EXPAREL 
administration were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, 
tremor, dizziness postural, paresthesia, syncope, incision site edema, procedural 
hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, 
pruritus generalized, rash pruritic, hyperhidrosis, cold sweat, urticaria, bradycardia, 
palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, 
ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, 
agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory 
failure, body temperature increased, blood pressure increased, blood pressure decreased, 
oxygen saturation decreased, urinary incontinence, vision blurred, tinnitus, drug 


 
 
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hypersensitivity, and hypersensitivity. Subject privacy will be protected as subject 
identifiers will be removed after data collection and before data analysis. 
 
13. 
BENEFIT(S) 
Patient may benefit if you are not in the control group and find less postoperative pain 
and/or shorter hospital stay.  In addition, the information learned from this study will 
determine if the drug has favorable outcomes on urologic surgeries. Future benefits may be 
present in improving the pain control after urologic surgeries and improve the overall 
patients’ satisfaction. 
 
14. 
COMPENSATION 
Subjects will receive no compensation. 
 
15. 
CONFIDENTIALITY 
Medical records will only be used for data collection and will be removed after data 
analysis. 
 
16. 
LITERATURE REVIEW 
1-Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain 
Control Following Mastectomy with Immediate Tissue Expander Reconstruction. 
Abdelsattar JM1, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim 
AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K,Jacobson 
SR, Lemaine V, Saint-Cyr M. 
2-Pilot study of a novel pain management strategy: evaluating the impact on patient 
outcomes. 
     Keller DS1, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM 
 
3-Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration 
with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A 
prospective randomized controlled study. 
Hutchins J1, Delaney D1, Vogel RI2, Ghebre RG3, Downs LS Jr3, Carson L3, Mullany 
S3, Teoh D3, Geller MA4. 
4- Impact of liposomal bupivacaine administration on postoperative pain in patients 
undergoing total knee replacement.  
White S1, Vaughan C2, Raiff D2, Eward W3, Bolognesi M2.