Clinical trial NCT04360421: Use of Long-acting Bupivacaine In Lower Extremity Amputation
Official title: Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Amputation
Anesthesia, Local
Opioid Use
Keywords: lower extremity amputation
liposomal bupivacaine
expedited recovery
vascular surgery
pain management
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total opioid use
timeFrame: Up to 4 weeks
measure: Total cost of stay
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Pain scores
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Department of Vascular Surgery
name: Kristyn Mannoia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motakef S, Wong WW, Ingargiola MJ, Nguyen D, Galdyn IA, Kim HY, Gupta SC. Liposomal Bupivacaine in Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Nov 20;5(11):e1559. doi: 10.1097/GOX.0000000000001559. eCollection 2017 Nov.
citation: Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
citation: Hyland SJ, Deliberato DG, Fada RA, Romanelli MJ, Collins CL, Wasielewski RC. Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):488-494. doi: 10.1016/j.arth.2018.11.026. Epub 2018 Nov 23.
citation: Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.
citation: Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.