Primary Outcome Measures:
- Total amount of opioid rescue analgesia used [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total amount of opioid rescue analgesia used [ Time Frame: 0 to 48 hours postoperatively ] [ Designated as safety issue: No ]
- The total amount of opioid rescue analgesia used [ Time Frame: 0 to 96 hours postoperatively ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Patient global evaluation of study treatment on a 5-point scale [ Time Frame: At 96 hours after Time 0 ] [ Designated as safety issue: No ]
- Changes in vital sign measurements [ Time Frame: Through 96 hours after Time 0 ] [ Designated as safety issue: Yes ]
- The incidence of treatment emergent Adverse Events [ Time Frame: Through 30 days after surgery ] [ Designated as safety issue: Yes ]
- Patient questionnaire [ Time Frame: 96 hours postoperatively ] [ Designated as safety issue: No ]
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.