Use of Long-acting Bupivacaine In Lower Extremity Amputation

Phase 4

Terminated

• Conditions: Amputation; Opioid Use; Anesthesia, Local
• Interventions: Drug: Liposomal bupivacaine

• Registration Number: NCT04360421
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-20
• Study Start: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Status Verified: 2023-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative liposomal bupivacaine field block	Liposomal bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Total opioid use	Up to 4 weeks	Total morphine equivalent
Total cost of stay	Up to 4 weeks	US Dollar cost

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States