Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
Condition: Lung Tumor
MeSH terms: Lung Neoplasms
Intervention: IV Acetaminophen; Saline Placebo
Intervention description: 1000mg IV Ofirmev given every six hours for a total of four doses.; Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: VATS; thoracic surgery; acetaminophen; ofirmev; lung surgery; thoracoscopic; intravenous acetaminophen

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.
    

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          -  Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure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