Lung Tumor | Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
Lung Tumor research study
What is the primary objective of 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. 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 is eligible to participate?
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of conversion to thoracotomy as determined by surgeon - Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:IV Acetaminophen1000mg IV Ofirmev given every six hours for a total of four doses.
Drug:Saline PlaceboNormal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Saline PlaceboSubjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
IV AcetaminophenSubjects 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.
Start Date: June 2013
Completed Date: July 2015
Phase: Phase 4
Primary Outcome: Total Morphine Consumption (mg)
Secondary Outcome: Total Number of PCA Requests in First 24 Hours Post-Operation
Study sponsors, principal investigator, and references
Principal Investigator: Hugh Hemmings, MD, PhD
Lead Sponsor: Weill Medical College of Cornell University