Use of Long-acting Bupivacaine In Lower Extremity Amputation

NCT04360421 | Terminated Phase 4 FDA Drug

• 1 other identifier: 5200004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Anesthesia, Local; Opioid Use

Keywords

lower extremity amputation; liposomal bupivacaine; expedited recovery; vascular surgery; pain management

Outcome Measures

Primary Outcomes (2)

• Total opioid use

  Total morphine equivalent

  Up to 4 weeks

• Total cost of stay

  US Dollar cost

  Up to 4 weeks

Secondary Outcomes (1)

• Pain scores

  Up to 4 weeks

Study Arms (1)

Intraoperative liposomal bupivacaine field block

EXPERIMENTAL

Patients will receive the maximum dosage of liposomal bupivacaine allowed for their body weight or the full vial, whichever is less. Injected once, along the incision before closure of the skin.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

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.

Intraoperative liposomal bupivacaine field block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (5)

• 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.

  PMID: 29263963 BACKGROUND

• 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.

  PMID: 25282071 BACKGROUND

• 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.

  PMID: 30554925 BACKGROUND

• 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.

  PMID: 30192328 BACKGROUND

• 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.

  PMID: 22900785 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristyn Mannoia, MD

  Loma Linda University Department of Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: April 21, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)