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Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: January 31, 2013
Last updated: March 4, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Video-assisted Thoracic Surgery
Drug: IV Acetaminophen
Drug: Saline Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 [ Time Frame: 24 hours ]
    How much morphine the subject consumes in the first 24 hours after surgery.

Secondary Outcome Measures:
  • Number of PCA morphine bolus requests [ Time Frame: 24 hours ]
    How many times the subject requests a "rescue" bolus of morphine for pain relief in the first 24 hours after surgery

  • Pain Scores [ Time Frame: 24 hours ]
    Subjects will be questioned about their pain levels at 1/2, 1, 2, 6, 8, and 24 hours following surgery using Visual Analog Scale scores and Verbal Rating Scale scores.

  • Vital signs [ Time Frame: 24 hours ]
    Vital signs including blood pressure, heart rate, respiratory rate, use of oxygen, and lowest oxygen delivery level will be measured at 1/2, 1, 2, 6, 8, and 24 hours after surgery.

  • Subject satisfaction [ Time Frame: 24 hours ]
    Subjects wil be questioned with a Likert rating scale (1=very dissatisfied to 5=very satisfied) at 8 hours and 24 hours

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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
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
Other Names:
  • Ofirmev
  • Paracetamol


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01783236

Contact: Hugh Hemmings, MD, PhD 212-746-2744
Contact: Sean Till, BA 212-746-2953

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

Additional Information:
Responsible Party: Weill Medical College of Cornell University Identifier: NCT01783236     History of Changes
Other Study ID Numbers: 1204012295
Study First Received: January 31, 2013
Last Updated: March 4, 2015

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

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics processed this record on April 26, 2017