NCT00749749

Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy

A Phase II, Randomized, Single-dose, Unblinded Study to Compare the Efficacy and Safety of the CollaRx Bupivacaine Implant With the ON-Q PainBuster Post-op Pain Relief System in Women Following Abdominal Hysterectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (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 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Detailed description

Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing hysterectomy is through an incision in the abdominal wall; however, about 20% are performed vaginally.Laparoscopic assisted vaginal hysterectomy is performed when warranted. Bupivacaine is a local anesthetic (pain medication) 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 cattle 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. The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0.25% bupivacaine; 1 soaker catheter measuring 12.5 cm in size; and a fill port, tubing, clamp, filter and flow restrictor. The pump provides positive pressure and is portable. It may be attached to the patient's dressing or placed in a carrying pouch. The catheter is inserted directly into the surgical wound providing a continuous flow of bupivacaine into the wound. A capillary flow restricting orifice located at the end of the tubing controls the flow rate. This study will compare the total narcotic use in patients with the CollaRx Bupivacaine Implant with the total narcotic use in patients with the ON Q PainBuster Post op Pain Relief System after abdominal hysterectomy.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)	The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
DRUG	ON-Q PainBuster Post-op Pain relief System	5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])

Timeline

• Start date: 2008-09-10
• Primary completion: 2008-12-22
• Completion: 2008-12-22
• First posted: 2008-09-09
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

1 site across 1 country: United States