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

Inclusion Criteria:

• Provide written Informed Consent prior to participation in the Study

• Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding,laparoscopic exploratory procedures in which no visceral dissection is performed, andlaparoscopic procedures with minimal visceral dissection, such as laparoscopicsterilization,are excluded)

• If Subject is a female of childbearing potential, have a negative pregnancy testwithin 21 days of surgery

• Be at least 18, but not more than 80 years of age

• Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2

• Have an American Society of Anesthesiologist (ASA) risk class of I, II, or III

• Have the ability to read and understand the Study procedures and the use of the painscales and have the ability to communicate meaningfully with the Study Investigatorand staff

• Be free of other physical, mental, or medical conditions which, in the opinion of theInvestigator, makes Study participation inadvisable

Exclusion Criteria:

• Used opioids or tramadol daily for greater than 7 days prior to Study Medicationadministration (Subjects who, in the Investigator's opinion have or are developingopioid 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 inthe Investigator's judgment could compromise the Subject's welfare, ability tocommunicate with the Study staff, complete Study activities, or would otherwisecontraindicate 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 theprevious 2 years

• Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alaninetransaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit ofnormal, active hepatic disease, evidence of clinically significant liver disease, orother condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest thepotential for an increased susceptibility to hepatic toxicity with Study Medicationexposure

• Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior tosurgery

• Has participated in another clinical Study (investigational or marketed product)within 30 days of surgery Post Operative Exclusion Criteria The Subject must not meet any of the following criteria prior to randomization to StudyMedication:

• Had any other surgery than the planned laparoscopic surgery or had intra operative orpost operative complications which in the view of the Investigator would make Studyparticipation inadvisable

• Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during theday after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, forcardioprophylaxis, 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) orcontinuous infusion by any route

• Had an epidural, regional, or percutaneous (intrawound) catheter with continuous localanesthetic 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 orsevere and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)