A Study of Loco-Regional Liposomal Bupivacaine Injection
Study Details
Study Description
Brief Summary
The purpose of this research is to find out if using liposomal bupivacaine solution (bupivacaine liposome) injections during lower extremity revascularization surgery will lower the amount of narcotic drugs used during and following the procedure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liposomal Bupivacaine Group Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery. |
Drug: Bupivacaine liposome
Injection into pelvic area and into the edges of wound at the end of the procedure.
|
| Placebo Comparator: Placebo Group Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery. |
Drug: Placebo
Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .
|
Outcome Measures
Primary Outcome Measures
- Postoperative use of narcotics at 12 hours [12 hours after injection]
Measured in morphine equivalent
- Postoperative use of narcotics at 24 hours [24 hours after injection]
Measured in morphine equivalent
- Postoperative use of narcotics at 48 hours [48 hours after injection]
Measured in morphine equivalent
- Postoperative use of narcotics at 72 hours [72 hours after injection]
Measured in morphine equivalent
- Postoperative use of narcotics at 30 days [30 days after injection]
Measured in morphine equivalent
Secondary Outcome Measures
- Postoperative quality of recovery at 14 days [14 days after injection]
Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
- Postoperative quality of recovery at 28 days [28 days after injection]
Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
- Intraoperative use of narcotics [During surgery approximately 2 to 6 hours]
Measured in morphine equivalent
- Hospital Length of Stay [28 days]
Total number of hours subjects were admitted to the hospital
Eligibility Criteria
Criteria
Inclusion Criteria:
- Those who present for elective lower extremity revascularization.
Exclusion Criteria:
-
Non-English speaking.
-
Chronic pain.
-
On opioids greater than 1 weeks.
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Allergy to local anesthetics.
-
Use of spinal or epidural for surgery.
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Lack of patient cooperation.
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Lontraindication to regional anesthesia.
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Vulnerable individuals.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Health System - Eau Claire | Eau Claire | Wisconsin | United States | 54703 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Tiziano Tallarita, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-003451