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Bupivacaine Effectiveness and Safety in SABER™ Trial

2014-08-27 03:16:33 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:33-0400

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Medical and Biotech [MESH] Definitions

A widely used local anesthetic agent.

A local anesthetic with rapid onset and long action, similar to BUPIVACAINE.

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).

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.

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)

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