Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

Exclusion Criteria

• •Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
• •Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
• •Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
• •Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
• •Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years
• •Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alanine transaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit of normal, active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with Study Medication exposure
• •Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior to surgery
• •Has participated in another clinical Study (investigational or marketed product) within 30 days of surgery
• •The Subject must not meet any of the following criteria prior to randomization to Study Medication:
• •Had any other surgery than the planned laparoscopic surgery or had intra operative or post operative complications which in the view of the Investigator would make Study participation inadvisable
• •Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during the day after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, for cardioprophylaxis, and limited use of topical or inhaled steroids are acceptable.
• •Had any neuraxial (spinal or epidural) opioid injected perioperatively
• •Had a local anesthetic injection (including into surgical wound at closure) or continuous infusion by any route
• •Had an epidural, regional, or percutaneous (intrawound) catheter with continuous local anesthetic infusion used for postoperative analgesic management
• •Had a fever (greater than 38.6 ºC or 101.5 ºF) requiring treatment
• •Post Operative Day 1 Randomization Criterion On the morning of the first post operative day (POD1), the Subject must have a categorical pain intensity score at rest of moderate or severe and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)