Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-28 @ 12:00 AM
Study NCT ID:
NCT02805504
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: