Bupivacaine Effectiveness and Safety in SABER™ Trial
Summary
This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.
The purpose of this study is to investigate safety (side effects) associated with the use of SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Postoperative Pain
Intervention
SABER™-Bupivacaine, Bupivacaine HCl, SABER™-Placebo
Location
DURECT Study Site
Florence
Alabama
United States
35630
Status
Recruiting
Source
Durect
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01052012
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:16:33-0400
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Medical and Biotech [MESH] Definitions
Bupivacaine
A widely used local anesthetic agent.
Etidocaine
A local anesthetic with rapid onset and long action, similar to BUPIVACAINE.
Etodolac
A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
Lidocaine
A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of procaine but its duration of action is shorter than that of bupivacaine or prilocaine.
Mepivacaine
A local anesthetic that is chemically related to BUPIVACAINE but pharmacologically related to LIDOCAINE. It is indicated for infiltration, nerve block, and epidural anesthesia. Mepivacaine is effective topically only in large doses and therefore should not be used by this route. (From AMA Drug Evaluations, 1994, p168)
