Use of Long-acting Bupivacaine In Lower Extremity Amputation

Sponsor

Loma Linda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04360421

Collaborator

(none)

Enrollment

Location

Arm

35.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation Anesthesia, Local Opioid Use	Drug: Liposomal bupivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 21, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraoperative liposomal bupivacaine field block 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 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.

Arm

Intervention/Treatment

Experimental: Intraoperative liposomal bupivacaine field block

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

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.

Outcome Measures

Primary Outcome Measures

Total opioid use [Up to 4 weeks]
Total morphine equivalent
Total cost of stay [Up to 4 weeks]
US Dollar cost

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Kristyn Mannoia, MD, Loma Linda University Department of Vascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Loma Linda University

ClinicalTrials.gov Identifier:

NCT04360421

Other Study ID Numbers:

5200004

First Posted:

Apr 24, 2020

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Loma Linda University

lower extremity amputation

liposomal bupivacaine

expedited recovery

vascular surgery

pain management

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of May 31, 2022