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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hysterectomy
• Intervention / Treatment: Drug: IV Acetaminophen; Drug: IV Placebo 100 mL solution

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.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV acetaminophen 1 g/100 mL solution	Drug: IV Acetaminophen; Intravenous acetaminophen 1 g/100 mL; Other Names: IV Acetaminophen (IV APAP)
Placebo Comparator: IV Placebo 100 mL solution	Drug: IV Placebo 100 mL solution; IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h); Other Names: IV Placebo (non-active product)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.	The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours.	Baseline (just prior to the first dose) through 24 hours
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo	The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours.	Baseline (just prior to the first dose) through 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)	First dose through 7 day follow up
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.	Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event	32 days following first dose of study medication.

Collaborators and Investigators

• Sponsor: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: November 14, 2006
• First Submitted That Met QC Criteria: November 14, 2006
• First Posted (Estimate): November 15, 2006

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Postoperative; Analgesic; IV Acetaminophen; Gynecologic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: CPI-APA-301