Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery

This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Inclusion Criteria:

• Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
• 18-75 years of age
• Body Mass Index (BMI) between 19-45
• American Society of Anesthesiologists (ASA) risk class of I, II, III
• Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
• Moderate to Severe pain at rest

Exclusion Criteria:

• Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
• Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
• Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
• Known history of alcohol or drug abuse or misuse
• Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
• Has significant medical disease(s), or conditions that may contraindicate participation in the study
• Has participated in another clinical trial within 30 days of surgery