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Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783236
First Posted: February 4, 2013
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.

Condition Intervention Phase
Lung Tumor Drug: IV Acetaminophen Drug: Saline Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Total Morphine Consumption (mg) [ Time Frame: 24 hours ]
    How much morphine the subject consumes in the first 24 hours after surgery (mg).


Secondary Outcome Measures:
  • Total Number of PCA Requests in First 24 Hours Post-Operation [ Time Frame: 24 hours post-operation ]
    The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation

  • VAS Pain Score 2 Hours Post Operation [ Time Frame: 2 Hours Post Operation ]
    2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

  • VAS Pain Score 6 Hours Post-Operation [ Time Frame: 6 Hours Post-Operation ]
    6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

  • VAS Score 24 Hours Post-Operation [ Time Frame: 24 hours post-operation ]
    24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).


Enrollment: 16
Study Start Date: June 2013
Study Completion Date: July 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Placebo
Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Drug: Saline Placebo
Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Other Name: Normal saline solution
Active Comparator: IV Acetaminophen
Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
Drug: IV Acetaminophen
1000mg IV Ofirmev given every six hours for a total of four doses.
Other Names:
  • Ofirmev
  • Paracetamol

Detailed Description:
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any elective VATS patients with low probability of conversion to thoracotomy as determined by surgery.
  • Ages 18-99
  • American Society of Anesthesiologists Physical Status I-III, hemodynamically stable
  • Male or female

Exclusion Criteria:

  • Age less than 18.
  • Patient refusal
  • High probability of conversion to thoracotomy as determined by surgeon
  • Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional anesthesia).
  • Scheduled procedure of VATS Pleurodesis/decortication
  • History of Interstitial Lung Disease
  • Emergency case
  • Known allergy/adverse reaction to acetaminophen, morphine, or fentanyl
  • History of drug or alcohol abuse
  • Patients on preoperative analgesic therapy within one week of surgery
  • Contraindication to self administered morphine (unable to understand PCA)
  • Need for postoperative mechanical ventilation
  • Necessary major deviation for intraoperative study protocol as per the discretion of the intraoperative attending anesthesiologist
  • History of congestive heart failure, renal failure, liver failure
  • Pregnant or breastfeeding women
  • Weight less than 51 kg
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783236


Locations
United States, New York
Weill Cornell Medical College
New York City, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Mallinckrodt
Investigators
Principal Investigator: Hugh Hemmings, MD, PhD Weill Medical College of Cornell University
  More Information

Additional Information:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01783236     History of Changes
Other Study ID Numbers: 1204012295
First Submitted: January 31, 2013
First Posted: February 4, 2013
Results First Submitted: February 3, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Keywords provided by Weill Medical College of Cornell University:
VATS
thoracic surgery
acetaminophen
ofirmev
lung surgery
thoracoscopic
intravenous acetaminophen

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics