Conditions: Postoperative Pain
Keywords: Post Operative Pain Hysterectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief 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.

Arms:
arm 1: A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure arm 2: A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure arm 3: The patient will recieve the standard of care, but no implant during surgery

Interventions: intervention 1: Bupivacaine Collagen Sponge (CollaRx®) intervention 2: placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: