Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

NCT01783236 | Completed Phase 4 Results

• 1 other identifier: 1204012295
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Tumor

Keywords

VATS; thoracic surgery; acetaminophen; ofirmev; lung surgery; thoracoscopic; intravenous acetaminophen

Outcome Measures

Primary Outcomes (1)

• Total Morphine Consumption (mg)

  How much morphine the subject consumes in the first 24 hours after surgery (mg).

  24 hours

Secondary Outcomes (4)

• Total Number of PCA Requests in First 24 Hours Post-Operation

  24 hours post-operation

• VAS Pain Score 2 Hours Post Operation

  2 Hours Post Operation

• VAS Pain Score 6 Hours Post-Operation

  6 Hours Post-Operation

• VAS Score 24 Hours Post-Operation

  24 hours post-operation

Study Arms (2)

Saline Placebo

PLACEBO COMPARATOR

Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

Drug: Saline Placebo

IV Acetaminophen

ACTIVE COMPARATOR

Subjects 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.

Drug: IV Acetaminophen

Interventions

IV Acetaminophen DRUG

1000mg IV Ofirmev given every six hours for a total of four doses.

Also known as: Ofirmev, Paracetamol

IV Acetaminophen

Saline Placebo DRUG

Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Also known as: Normal saline solution

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Mallinckrodt: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Links

• Label information for acetaminophen (ofirmev)

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Hugh Hemmings, MD, PhD
• Organization: Weill Cornell Medicine

hchemmi@med.cornell.edu

212-746-2953

Study Officials

• Hugh Hemmings, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)