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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01783236
Other study ID # 1204012295
Secondary ID
Status Recruiting
Phase Phase 4
First received January 31, 2013
Last updated March 4, 2015
Start date June 2013
Est. completion date December 2016

Study information

Verified date March 2015
Source Weill Medical College of Cornell University
Contact Hugh Hemmings, MD, PhD
Phone 212-746-2744
Email hchemmi@med.cornell.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
IV Acetaminophen

Saline Placebo


Locations

Country Name City State
United States Weill Cornell Medical College New York City New York

Sponsors (2)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total morphine consumption How much morphine the subject consumes in the first 24 hours after surgery. 24 hours No
Secondary Number of PCA morphine bolus requests How many times the subject requests a "rescue" bolus of morphine for pain relief in the first 24 hours after surgery 24 hours No
Secondary Pain Scores 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. 24 hours No
Secondary Vital signs 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. 24 hours No
Secondary Subject satisfaction Subjects wil be questioned with a Likert rating scale (1=very dissatisfied to 5=very satisfied) at 8 hours and 24 hours 24 hours No
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