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RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
Prospective, randomized, controlled single-blinded 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. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Manhattan Eyes Ears and Throat Hospital
New York, New York, United States
Start Date
June 16, 2020
Primary Completion Date
June 1, 2022
Completion Date
June 1, 2022
Last Updated
February 25, 2021
100
ESTIMATED participants
Liposomal bupivacaine
DRUG
Bupivacaine HCl
DRUG
Lead Sponsor
Alexandra Black
NCT06862609
NCT07327463
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07436806