Loco-Regional Liposomal Bupivacaine Injection in Lower Extremity Revascularization
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Eau Claire, Wisconsin: 23-003451
NCT ID: NCT05992896
About this study
The purpose of this study is to compare loco-regional liposomal bupivacaine injection versus normal saline (placebo control group) to assess possible reduction of intra- and post- operative narcotic use with liposomal bupivacaine, in patients undergoing lower extremity revascularization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥ 18 years of age.
- All males.
- Females if sterile (history of tubal ligation or hysterectomy) and/or last menses was > 1 year ago.
- Elective lower extremity revascularization is scheduled or being scheduled.
Exclusion Criteria:
- Non-English speaking.
- Chronic pain, currently requiring opioids.
- On opioids greater than 1 weeks.
- Allergy to local anesthetics.
- Use of spinal or epidural for surgery.
- Lack of patient cooperation.
- Contraindication to regional anesthesia.
- Vulnerable individuals.
- Urgent/emergent surgeries.
- Known to be pregnant or able to become pregnant.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Eau Claire, Wis.
Mayo Clinic principal investigator Tiziano Tallarita, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available