Amputation, Anesthesia, Local, Opioid Use
Conditions
Keywords
lower extremity amputation, liposomal bupivacaine, expedited recovery, vascular surgery, pain management
Brief 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.
Interventions
DRUGLiposomal 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.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Patients who underwent unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral \[1 year retrospective analysis\] * Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral
Exclusion criteria
* Minor amputations * Liver dysfunction (impaired metabolism of Amides) * Concomitant psychiatric or chronic pain disorders * Pregnancy * Amide anesthetic allergy * Presence of perioperative sepsis or acute organ dysfunction * Need for ICU admission at any point * Polytrauma * Quadriplegic/Paraplegic/Insensate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid use | Up to 4 weeks | Total morphine equivalent |
| Total cost of stay | Up to 4 weeks | US Dollar cost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | Up to 4 weeks | Numeric rating scale of 0 to 10, where 0 is no pain and 10 is the worst possible pain. |
Countries
United States
Outcome results
None listed