Use of Long-acting Bupivacaine In Lower Extremity Amputation

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04360421
• Other study ID #: 5200004
• Status: Terminated
• Phase: Phase 4
• Start date: April 21, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Anesthesia, Local
• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid use	Total morphine equivalent	Up to 4 weeks
Primary	Total cost of stay	US Dollar cost	Up to 4 weeks
Secondary	Pain scores	Numeric rating scale of 0 to 10, where 0 is no pain and 10 is the worst possible pain.	Up to 4 weeks