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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
Sponsor:
Information provided by (Responsible Party):
D. Duane Baldwin, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Diseases Drug: Exparel Drug: Marcaine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exparel
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Drug: Exparel
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.
Drug: Marcaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Other Name: Bupivacaine HCl




Primary Outcome Measures :
  1. Total opioid consumption [ Time Frame: Postoperative day1-3 ]
    Postoperative analgesic use will be measured in oral morphine equivalents dose

  2. Postoperative pain assessment [ Time Frame: Postoperative day1-3 ]
    Pain score (1-10) will be used.

  3. Length of Hospital Stay and readmission [ Time Frame: 30 days postoperatively ]
  4. Postoperative complications [ Time Frame: 30 days postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mohamed Keheila, MD 909 558 4196 ext 44196 mkeheila@llu.edu

Locations
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United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Mohamed Keheila         
Sponsors and Collaborators
Loma Linda University
Investigators
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Study Director: Mohamed Keheila, MD Loma Linda University Medical Center
Publications:
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Responsible Party: D. Duane Baldwin, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02805504    
Other Study ID Numbers: 5160165
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by D. Duane Baldwin, Loma Linda University:
Bupivacaine
Minimally Invasive Surgical Procedures
Additional relevant MeSH terms:
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Urologic Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents