Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Primary Purpose
Urinary Tract Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Marcaine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Diseases focused on measuring Bupivacaine, Minimally Invasive Surgical Procedures
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing urologic surgery.
Exclusion Criteria:
- Pregnant and/or nursing mothers.
- Allergy to bupivacaine.
- History of drug/alcohol abuse.
- Severe cardiovascular, hepatic, renal disease or neurological impairment.
Sites / Locations
- Loma Linda Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exparel
Marcaine
Arm Description
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Outcomes
Primary Outcome Measures
Total opioid consumption
Postoperative analgesic use will be measured in oral morphine equivalents dose
Postoperative pain assessment
Pain score (1-10) will be used.
Length of Hospital Stay and readmission
Postoperative complications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02805504
Brief Title
Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Official Title
Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Diseases
Keywords
Bupivacaine, Minimally Invasive Surgical Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Experimental
Arm Description
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Arm Title
Marcaine
Arm Type
Active Comparator
Arm Description
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
liposomal bupivacaine
Intervention Description
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
Intervention Type
Drug
Intervention Name(s)
Marcaine
Other Intervention Name(s)
Bupivacaine HCl
Intervention Description
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Primary Outcome Measure Information:
Title
Total opioid consumption
Description
Postoperative analgesic use will be measured in oral morphine equivalents dose
Time Frame
Postoperative day1-3
Title
Postoperative pain assessment
Description
Pain score (1-10) will be used.
Time Frame
Postoperative day1-3
Title
Length of Hospital Stay and readmission
Time Frame
30 days postoperatively
Title
Postoperative complications
Time Frame
30 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing urologic surgery.
Exclusion Criteria:
Pregnant and/or nursing mothers.
Allergy to bupivacaine.
History of drug/alcohol abuse.
Severe cardiovascular, hepatic, renal disease or neurological impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Keheila, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26307232
Citation
Abdelsattar JM, 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. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.
Results Reference
background
PubMed Identifier
26056753
Citation
Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
Results Reference
background
PubMed Identifier
25940854
Citation
White S, Vaughan C, Raiff D, Eward W, Bolognesi M. Impact of liposomal bupivacaine administration on postoperative pain in patients undergoing total knee replacement. Pharmacotherapy. 2015 May;35(5):477-81. doi: 10.1002/phar.1587. Epub 2015 May 4.
Results Reference
background
Learn more about this trial
Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
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