US medical center started a clinical trial of Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

Photo by Christopher Sardegna

Lenox Hill Hospital is enrolling patients into the clinical trial investigating Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery.

This trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. The hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.

The trial is designed to enroll male and female 18 years and older and is being conducted in the Manhattan Eyes Ears and Throat Hospital, New York, United States.

The study start date is June 16, 2020.

The population that are excluded from participation:

• Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week.
• Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery.
• Systemic glucocorticoids within 1 month of study enrollment.
• History of hepatitis.
• History of peripheral vascular disease.
• History of diabetes mellitus type 1 or 2.
• Pregnancy or lactation.
• Allergic to opioids.
• Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA.
• BMI > 40

Lenox Hill Hospital (LHH) is a nationally ranked 449-bed non-profit, tertiary, research and academic medical center located at the Upper East Side of Manhattan, New York City, New York, servicing the general area. LHH is one of the region's many university-level academic medical centers. The hospital is owned by Northwell Health and is one of the largest hospitals in the system. LHH is affiliated with the Hofstra Northwell School of Medicine, New York University School of Medicine, New York Medical College, and State University of New York Downstate Medical Center College of Medicine.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04751344