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

Phase 3

Completed

• Conditions: Postoperative Pain; Hysterectomy
• Interventions: Drug: IV Acetaminophen; Drug: IV Placebo 100 mL solution

• Registration Number: NCT00399568
• Lead Sponsor: Mallinckrodt

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Disposition First Submitted: 2009-04-03
• Results First Submitted: 2009-09-25
• Results First Submitted QC: 2010-11-11
• Disposition First Submitted QC: 2010-11-11
• Results First Posted: 2010-12-10
• Disposition First Posted: 2010-12-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 331

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV acetaminophen 1 g/100 mL solution	IV Acetaminophen	-
IV Placebo 100 mL solution	IV Placebo 100 mL solution	-

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.	Baseline (just prior to the first dose) through 24 hours	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	Baseline (just prior to the first dose) through 48 hours	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

Name	Time	Method
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.	32 days following first dose of study medication.	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
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	First dose through 7 day follow up	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)

Trial Locations

Locations (27)

University of Alabama (Anesthesiology); 🇺🇸 Birmingham, Alabama, United States

Helen Keller Hospital; 🇺🇸 Sheffield, Alabama, United States

Arizona Research Center, Inc (JC Lincoln); 🇺🇸 Phoenix, Arizona, United States

Arizona Research Center, Inc. (Arrowhead); 🇺🇸 Phoenix, Arizona, United States

Precision Trials; 🇺🇸 Phoenix, Arizona, United States

Arcadia Methodist Hospital; 🇺🇸 Arcadia, California, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States

Accurate Clinical Trials, Inc.; 🇺🇸 San Clemente, California, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

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