NCT00624910

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Innocoll · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine Collagen Sponge (CollaRx®)	The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
DRUG	placebo	The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

Timeline

• Start date: 2007-12-27
• Primary completion: 2008-09-05
• Completion: 2008-09-05
• First posted: 2008-02-28
• Last updated: 2021-07-23
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study