Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

• SPI after aggravated movement (cough) [ Time Frame: through 48 hours after surgery ] [ Designated as safety issue: No ]
• SPI and individual VAS PI score at rest [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]
• Total use of opioid analgesia [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]

• SPI after aggravated movement (cough) [ Time Frame: through 48 hours after surgery ] [ Designated as safety issue: No ]
• SPI and individual VAS PI score at rest [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]
• Total use of opioid analgesia [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]
• SPI and individual pain intensity rating on a 4-point categorical scale at rest and after aggravated movement (cough) [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]
• Patient global evaluation of study treatment on a 5 point categorical scale [ Time Frame: At 72 hours after time 0 ] [ Designated as safety issue: No ]
• Incidence of opioid-related side effects [ Time Frame: up to 1 week after open laparotomy inguinal herniorrhaphy ] [ Designated as safety issue: Yes ]
• Time to first use of oral opioid rescue medication [ Time Frame: within 24 hrs ] [ Designated as safety issue: No ]
• Vital signs (Heart rate, respiratory rate, systolic and diastolic blood pressure and body temperature) [ Time Frame: through 72 after surgery ] [ Designated as safety issue: Yes ]
• Treatment emergent adverse events [ Time Frame: Through 30 days after surgery ] [ Designated as safety issue: Yes ]

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

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 assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

• Herniorrhaphy
• Postoperative Pain
• Inguinal Hernia

• Drug: Bupivacaine Collagen Sponge
  Drug: Bupivacaine Collagen Sponge
  Other Name: Bupivacaine Implant
• Drug: Placebo collagen Sponge
  Drug: Placebo Collagen Sponge
  Other Name: Collagen Implant

• Experimental: 2, 5x5cm bupivacaine collagen sponges
  Intervention: Drug: Bupivacaine Collagen Sponge
• Placebo Comparator: 2, Placebo collagen sponges
  Intervention: Drug: Placebo collagen Sponge

Inclusion Criteria:

• Man ≥ 18 years
• Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
• Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.

Exclusion Criteria:

• Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
• Scheduled for bilateral inguinal herniorrhaphy.
• Undergone a prior herniorrhaphy on the side scheduled for repair.
• Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
• Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
• Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
• Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.