This study will be investigating the efficacy and safety administration of multiple doses of
IV Acetaminophen 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
- BMI between 19-45
- 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 (AST/ALT/bilirubin) greater than or equal to 2x 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
University of Alabama (Anesthesiology), Birmingham, Alabama 35249, United States
Helen Keller Hospital, Sheffield, Alabama 35660, United States
Arizona Research Center, Inc. (Arrowhead), Phoenix, Arizona 85023, United States
Arizona Research Center, Inc (JC Lincoln), Phoenix, Arizona 85023, United States
Precision Trials, Phoenix, Arizona 85032, United States
Accurate Clinical Trials, Inc., San Clemente, California 92672, United States
Huntington Memorial Hospital, Pasadena, California 91105, United States
Arcadia Methodist Hospital, Arcadia, California 91007, United States
Glendale Adventist Medical Center, Glendale, California 91206, United States
Visions Clinical Research, Boynton Beach, Florida 33414, United States
University of Miami School of Medicine Dept. of Anesthesiology, Miami, Florida 33136, United States
Nature Coast Clinical Research, Inverness, Florida 34452, United States
G and G Research, Inc., Fort Pierce, Florida 34950, United States
Century Clinical Research, INC, Holly Hill, Florida 32117, United States
Treasure Coast Obstetrics and Gynecology, Vero Beach, Florida 32960, United States
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Cooper Anesthesia, Camden, New Jersey 08103, United States
St. Peters University Hospital, Anesthesiology, New Brunswick, New Jersey 08901, United States
Weill Medical College, New York, New York 10021, United States
Stony Brook Anesthesiology Health Sciences Cente, Stony Brook, New York 11794, United States
Jacobi Medical Center (Albert Einstein College of Medicine), Bronx, New York 10461, United States
Albany Medical College Dept. of Anesthesiology, Albany, New York 11208, United States
The Ohio State University Medical Center, Columbus, Ohio 43210, United States
Allegheny Pain Managment, Altoona, Pennsylvania 16602, United States
Thomas Jefferson University Dept. of Anesthesiology, Philadelphia, Pennsylvania 19107, United States
Memorial Herman/Memorial City Hospital, Houston, Texas 77024, United States
Texas Woman's Hospital, Houston, Texas 77024, United States
