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Completed

NCT Number: NCT00399568

Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op 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.

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Key information

Conditions

Postoperative Pain Hysterectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama (Anesthesiology), Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen

Drug

Intravenous acetaminophen 1 g/100 mL

Other names: IV Acetaminophen (IV APAP)

IV Placebo 100 mL solution

Drug

IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)

Other names: IV Placebo (non-active product)

Primary outcomes

  1. Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.

    Time frame: 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.

  2. Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo

    Time frame: 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 outcomes

  1. Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: 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)

  2. Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2006
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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