Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2013 |
| End Date: | December 2016 |
| Contact: | Hugh Hemmings, MD, PhD |
| Email: | hchemmi@med.cornell.edu |
| Phone: | 212-746-2744 |
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
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.
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.
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
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