Viewing Study NCT03638635


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Study NCT ID: NCT03638635
Status: TERMINATED
Last Update Posted: 2019-09-09
First Post: 2017-08-21
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
Sponsor: Inova Health Care Services
Organization:

Study Overview

Official Title: TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Status: TERMINATED
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lack of personnel available to complete study.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.
Detailed Description: Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Study Oversight

Has Oversight DMC: False
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?: