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Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy

Postoperative Pain Clinical Trial

Official title:
A Phase II, Single-dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure

Clinical Trial Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.

Clinical Trial Description

Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. This study will compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00624910
Study type Interventional
Source Innocoll
Contact
Status Completed
Phase Phase 2
Start date December 27, 2007
Completion date September 5, 2008
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