NCT04360421

Use of Long-acting Bupivacaine In Lower Extremity Amputation

Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.

Conditions

• Amputation
• Anesthesia, Local
• Opioid Use

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Patient's undergoing major extremity amputation and enrolled in the study as part of the experimental arm will, during their amputation operation, receive liposomal bupivicaine per recommended manufacturing dosing and administration in a "field block" for long-acting local anesthesia.

Timeline

• Start date: 2020-04-21
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2020-04-24
• Last updated: 2023-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study