Your session is about to expire
← Back to Search
Liposomal Bupivacaine for Peripheral Arterial Disease
Phase 4
Recruiting
Led By Tiziano Tallarita, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial aims to see if liposomal bupivacaine injections can reduce the need for painkiller drugs during and after lower limb revascularization surgery.
Who is the study for?
This trial is for English-speaking individuals scheduled for elective lower extremity revascularization surgery who are not on opioids for more than a week, do not have chronic pain, and have no allergies to local anesthetics or contraindications to regional anesthesia.Check my eligibility
What is being tested?
The study is testing if injections of liposomal bupivacaine can reduce the need for narcotic drugs during and after leg artery surgery. Participants will either receive the actual drug or a placebo without knowing which one they get.See study design
What are the potential side effects?
Liposomal bupivacaine may cause side effects such as numbness in the area of injection, low blood pressure, nausea, vomiting, backache, headache or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative use of narcotics at 12 hours
Postoperative use of narcotics at 24 hours
Postoperative use of narcotics at 30 days
+2 moreSecondary outcome measures
Hospital Length of Stay
Intraoperative use of narcotics
Postoperative quality of recovery at 14 days
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liposomal Bupivacaine GroupExperimental Treatment1 Intervention
Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine liposome
2016
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,468 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
260 Patients Enrolled for Peripheral Arterial Disease
Tiziano Tallarita, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Long-lasting painYou have been taking opioid medications for more than 1 week.You had a spinal or epidural procedure for surgery.You are not willing to cooperate with the study requirements.You are allergic to local anesthesia.You cannot have regional anesthesia for medical reasons.You are scheduled for a planned surgery to improve blood flow in your legs.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: Liposomal Bupivacaine Group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aim of this experiment?
"This clinical trial's primary objective is to quantify the postoperative use of narcotics within 24 hours. Secondary outcomes include a self-reported Quality of Recovery score, opioid consumption during surgery, and Hospital Length Of Stay. These metrics are all assessed on 11 point Likert scales or in morphine equivalents with higher scores indicating better results."
Answered by AI
How hazardous is the usage of Liposomal Bupivacaine Group to those taking part in treatment?
"Liposomal Bupivacaine Group is sanctioned by regulatory authorities, leading to an evaluation score of 3."
Answered by AI
Is recruitment for this clinical experiment still taking place?
"According to clinicaltrials.gov, this experiment is not actively recruiting participants at present. First posted on September 5th 2023 and last updated on August 7th of the same year, there are no current positions available for potential candidates though other trials may be seeking enrolment right now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger