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Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

Primary Purpose

Postoperative Pain, Hysterectomy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
IV Placebo 100 mL solution
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Gynecologic, IV Acetaminophen, Postoperative, Analgesic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama (Anesthesiology)
  • Helen Keller Hospital
  • Arizona Research Center, Inc (JC Lincoln)
  • Arizona Research Center, Inc. (Arrowhead)
  • Precision Trials
  • Arcadia Methodist Hospital
  • Glendale Adventist Medical Center
  • Huntington Memorial Hospital
  • Accurate Clinical Trials, Inc.
  • Visions Clinical Research
  • G and G Research, Inc.
  • Century Clinical Research, INC
  • Nature Coast Clinical Research
  • University of Miami School of Medicine Dept. of Anesthesiology
  • Treasure Coast Obstetrics and Gynecology
  • William Beaumont Hospital
  • Cooper Anesthesia
  • St. Peters University Hospital, Anesthesiology
  • Albany Medical College Dept. of Anesthesiology
  • Jacobi Medical Center (Albert Einstein College of Medicine)
  • Weill Medical College
  • Stony Brook Anesthesiology Health Sciences Cente
  • The Ohio State University Medical Center
  • Allegheny Pain Managment
  • Thomas Jefferson University Dept. of Anesthesiology
  • Memorial Herman/Memorial City Hospital
  • Texas Woman's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV acetaminophen 1 g/100 mL solution

IV Placebo 100 mL solution

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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

Full Information

First Posted
November 14, 2006
Last Updated
September 8, 2016
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00399568
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hysterectomy
Keywords
Pain, Gynecologic, IV Acetaminophen, Postoperative, Analgesic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV acetaminophen 1 g/100 mL solution
Arm Type
Experimental
Arm Title
IV Placebo 100 mL solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
IV Acetaminophen (IV APAP)
Intervention Description
Intravenous acetaminophen 1 g/100 mL
Intervention Type
Drug
Intervention Name(s)
IV Placebo 100 mL solution
Other Intervention Name(s)
IV Placebo (non-active product)
Intervention Description
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Primary Outcome Measure Information:
Title
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
Description
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.
Time Frame
Baseline (just prior to the first dose) through 24 hours
Title
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
Description
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.
Time Frame
Baseline (just prior to the first dose) through 48 hours
Secondary Outcome Measure Information:
Title
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Description
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)
Time Frame
First dose through 7 day follow up
Title
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
Description
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
Time Frame
32 days following first dose of study medication.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama (Anesthesiology)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Helen Keller Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Arizona Research Center, Inc (JC Lincoln)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Arizona Research Center, Inc. (Arrowhead)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arcadia Methodist Hospital
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Accurate Clinical Trials, Inc.
City
San Clemente
State/Province
California
ZIP/Postal Code
92672
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
G and G Research, Inc.
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
Century Clinical Research, INC
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
University of Miami School of Medicine Dept. of Anesthesiology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Treasure Coast Obstetrics and Gynecology
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Cooper Anesthesia
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Peters University Hospital, Anesthesiology
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Albany Medical College Dept. of Anesthesiology
City
Albany
State/Province
New York
ZIP/Postal Code
11208
Country
United States
Facility Name
Jacobi Medical Center (Albert Einstein College of Medicine)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Stony Brook Anesthesiology Health Sciences Cente
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Allegheny Pain Managment
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Thomas Jefferson University Dept. of Anesthesiology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Memorial Herman/Memorial City Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Woman's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

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