Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

Video-assisted Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01783236
• Other study ID #: 1204012295
• 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

• Video-assisted Thoracic Surgery

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

External Links

•   Label information for acetaminophen (ofirmev)