Clinical trial NCT00399568: Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Hysterectomy
Keywords: Pain
Gynecologic
IV Acetaminophen
Postoperative
Analgesic
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 331
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
timeFrame: Baseline (just prior to the first dose) through 24 hours
measure: Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
timeFrame: Baseline (just prior to the first dose) through 48 hours
Secondary outcomes:
measure: Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: First dose through 7 day follow up
measure: Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
timeFrame: 32 days following first dose of study medication.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama (Anesthesiology)
state: Alabama
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center, Inc (JC Lincoln)
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc. (Arrowhead)
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Arcadia
country: United States
facility: Arcadia Methodist Hospital
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Clemente
country: United States
facility: Accurate Clinical Trials, Inc.
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Fort Pierce
country: United States
facility: G and G Research, Inc.
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research, INC
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine Dept. of Anesthesiology
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Obstetrics and Gynecology
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper Anesthesia
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peters University Hospital, Anesthesiology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College Dept. of Anesthesiology
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center (Albert Einstein College of Medicine)
state: New York
city: New York
country: United States
facility: Weill Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Anesthesiology Health Sciences Cente
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Managment
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Dept. of Anesthesiology
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Herman/Memorial City Hospital
state: Texas
city: Houston
country: United States
facility: Texas Woman's Hospital
state: Texas
Study officials:
References: