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Completed

NCT Number: NCT01783236

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

IV acetaminophen

Drug

1000mg IV Ofirmev given every six hours for a total of four doses.

Other names: Ofirmev, Paracetamol

Saline placebo

Drug

Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Other names: Normal saline solution

Primary outcomes

  1. Total Morphine Consumption (mg)

    Time frame: 24 hours

    How much morphine the subject consumes in the first 24 hours after surgery (mg).

Secondary outcomes

  1. 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

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Mallinckrodt

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2013
Registry last updated
May 11, 2017

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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