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Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

Primary Purpose

Lung Tumor

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
Saline Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Tumor focused on measuring VATS, thoracic surgery, acetaminophen, ofirmev, lung surgery, thoracoscopic, intravenous acetaminophen

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline Placebo

IV Acetaminophen

Arm Description

Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

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.

Outcomes

Primary Outcome Measures

Total Morphine Consumption (mg)
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
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
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
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
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).

Full Information

First Posted
January 31, 2013
Last Updated
March 31, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01783236
Brief Title
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Tumor
Keywords
VATS, thoracic surgery, acetaminophen, ofirmev, lung surgery, thoracoscopic, intravenous acetaminophen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Arm Title
IV Acetaminophen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev, Paracetamol
Intervention Description
1000mg IV Ofirmev given every six hours for a total of four doses.
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Other Intervention Name(s)
Normal saline solution
Intervention Description
Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Primary Outcome Measure Information:
Title
Total Morphine Consumption (mg)
Description
How much morphine the subject consumes in the first 24 hours after surgery (mg).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total Number of PCA Requests in First 24 Hours Post-Operation
Description
The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation
Time Frame
24 hours post-operation
Title
VAS Pain Score 2 Hours Post Operation
Description
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).
Time Frame
2 Hours Post Operation
Title
VAS Pain Score 6 Hours Post-Operation
Description
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).
Time Frame
6 Hours Post-Operation
Title
VAS Score 24 Hours Post-Operation
Description
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).
Time Frame
24 hours post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Hemmings, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York City
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD
Links:
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf
Description
Label information for acetaminophen (ofirmev)

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Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

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