Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy
|Pain, Postoperative||Device: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) Device: ON-Q PainBuster Post-op Pain relief System||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Total amount of opioid rescue analgesia used [ Time Frame: 0 to 24 hours postoperatively ]
- Total amount of opioid rescue analgesia used [ Time Frame: 0 to 48 hours postoperatively ]
- The total amount of opioid rescue analgesia used [ Time Frame: 0 to 96 hours postoperatively ]
- Pain intensity rating on the Visual Analogue Scale (VAS) [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours after Time 0 ]
- Pain intensity on a 4-point scale [ Time Frame: At 30 minutes and 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours after Time 0 ]
- Pain relief on a 5-point scale [ Time Frame: At 30 minutes and 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 48, 72 and 96 hours after Time 0 ]
- Patient global evaluation of study treatment on a 5-point scale [ Time Frame: At 96 hours after Time 0 ]
- Changes in vital sign measurements [ Time Frame: Through 96 hours after Time 0 ]
- The incidence of treatment emergent Adverse Events [ Time Frame: Through 30 days after surgery ]
- Patient questionnaire [ Time Frame: 96 hours postoperatively ]
|Study Start Date:||September 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Device: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)
The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
Other Name: CollRx Bupivacaine Implant
Active Comparator: 2
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
Device: 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])
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749749
|United States, Florida|
|Visions Clinical Research|
|Boynton Beach, Florida, United States, 33472|
|Study Director:||David Prior||Innocoll|