Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
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|ClinicalTrials.gov Identifier: NCT02805504|
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Diseases||Drug: Exparel Drug: Marcaine||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
Other Name: liposomal bupivacaine
Active Comparator: Marcaine
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Other Name: Bupivacaine HCl
- Total opioid consumption [ Time Frame: Postoperative day1-3 ]Postoperative analgesic use will be measured in oral morphine equivalents dose
- Postoperative pain assessment [ Time Frame: Postoperative day1-3 ]Pain score (1-10) will be used.
- Length of Hospital Stay and readmission [ Time Frame: 30 days postoperatively ]
- Postoperative complications [ Time Frame: 30 days postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805504
|Contact: Mohamed Keheila, MD||909 558 4196 ext email@example.com|
|United States, California|
|Loma Linda Medical Center||Recruiting|
|Loma Linda, California, United States, 92350|
|Contact: Mohamed Keheila|
|Study Director:||Mohamed Keheila, MD||Loma Linda University Medical Center|