Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01783236
First received: January 31, 2013
Last updated: September 5, 2013
Last verified: September 2013
  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. 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective VATS patients for wedge resection 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783236

Contacts
Contact: Hugh Hemmings, MD, PhD 212-746-2744 hchemmi@med.cornell.edu
Contact: Sean Till, BA 212-746-9419 set2009@med.cornell.edu

Locations
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
Cadence Pharmaceuticals
Investigators
Principal Investigator: Hugh Hemmings, MD, PhD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01783236     History of Changes
Other Study ID Numbers: 1204012295
Study First Received: January 31, 2013
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014