Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Launched by RYAN MOUNTJOY, MD · Nov 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for managing pain after below-the-knee amputations: liposomal bupivacaine, which is a long-lasting numbing medication, and continuous nerve catheters, which are tubes that deliver medication directly to the nerves. The goal is to see which method helps patients feel less pain after their surgery. This study is being conducted at Maine Medical Center and is currently looking for participants.

To be eligible for this trial, patients need to be scheduled for a primary amputation or a revision of their stump and should be between the ages of 65 and 74. They should also be able to speak English and fit into specific health guidelines. Participants can expect to receive one of the two pain management treatments and will help researchers gather important information that will be used for future studies. It's important to note that some individuals may not qualify, such as those with certain allergies, infections, or other health issues.

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Eligibility criteria

• Inclusion Criteria:
• • American Society of Anesthesiologists Physical Status Classification I-IV
• • Scheduled for primary amputation or stump revision
• • English speaking
• Exclusion Criteria:
• • Patients unable to cooperate or consent to the study
• • Allergy to local anesthetics
• • Existing infection at planned needle insertion site
• • BMI \> 40kg/m2
• • Patients with a history of coagulopathy
• • Emergency amputations
• • Contralateral amputations
• • Patients with a substance use disorder diagnosis
• • Patients on opioids \>90 morphine milligram equivalents (MME)/day