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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 11, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- Weill Medical College of Cornell University
- Interventions being studied
- Drug: IV Acetaminophen; Drug: Saline Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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- Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Weill Cornell Medical CollegeNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 11, 2017. Always confirm current availability with the study team.