Viewing Study NCT05891613



Ignite Creation Date: 2024-05-06 @ 7:06 PM
Last Modification Date: 2024-10-26 @ 3:00 PM
Study NCT ID: NCT05891613
Status: RECRUITING
Last Update Posted: 2024-04-17
First Post: 2023-05-26

Brief Title: A Study of Liposomal Bupivacaine Versus 025 Bupivacaine Hydrochloride Post Breast Reduction
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: Liposomal Bupivacaine Versus 025 Bupivacaine Hydrochloride for Postoperative Analgesia After Breast Reduction Surgery A Prospective Single Blind Non-randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this research is to assess pain scores and opioid use when using Liposomal Exparel Bupivacaine versus Bupivacaine Hydrochloride
Detailed Description: This is a prospective multi-surgeon single blind non-randomized controlled trial with breasts allocated to two parallel groups A mixture of liposomal Exparel bupivacaine with plain 025 bupivacaine hydrochloride will be used on one side Treatment side as local infiltration and plain 025 Bupivacaine Hydrochloride will be used in the control arm Each breast will serve as the control for the other The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively These treatments are standard of care in clinical practice

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None