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Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery (IVTylenol)

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ClinicalTrials.gov Identifier: NCT03051932
Recruitment Status : Withdrawn (Not funded)
First Posted : February 14, 2017
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date February 5, 2019
Estimated Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
The amount of postoperative narcotic used. [ Time Frame: Within 7 days of surgery ]
the amount of postoperative narcotic used, after surgery.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • The amount of postoperative narcotic used. [ Time Frame: Within 7 days of surgery ]
    the amount of postoperative narcotic used, after surgery.
  • The amount of postoperative pain. [ Time Frame: An average of 4 days ]
    The amount of postoperative patient assessment of pain as measured by a validated pain survey (NRS)
  • length of stay in the hospital [ Time Frame: An average of 4 days ]
    length of stay in the hospital from admission to discharge of patient after surgery.
  • The amount of postoperative pain. [ Time Frame: Within 2-4 weeks of surgery ]
    The amount of postoperative patient assessment of pain as measured by patient satisfaction survey on 2-4 weeks post-op clinic follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • The amount of postoperative pain. [ Time Frame: An average of 4 days ]
    The amount of postoperative patient assessment of pain as measured by a validated pain survey (NRS)
  • length of stay in the hospital [ Time Frame: An average of 4 days ]
    length of stay in the hospital from admission to discharge of patient after surgery.
  • The amount of postoperative pain. [ Time Frame: Within 2-4 weeks of surgery ]
    The amount of postoperative patient assessment of pain as measured by patient satisfaction survey on 2-4 weeks post-op clinic follow-up.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery
Official Title  ICMJE Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery
Brief Summary This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.
Detailed Description

This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 patient per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA. All patients will be enrolled from a single site.50 patient will be enrolled in each arm (placebo/ acetamophin). Each subject will be administered a single dose of study drug or placebo infused over 15-minutes, four times, six hours apart. The duration of subject participation will be ten weeks. Total duration of the study is expected to be 52 weeks. The primary endpoints of the study will be the amount of postoperative narcotic used, patient assessment of pain as measured by a validated pain survey, and length of stay in the hospital.

For postoperative pain assessment, the Numeric Rating Scale (NRS) will be used (NRS: 0-10; 0: no pain, 10: worst pain imaginable). Pain will be evaluated at 2-hour intervals in the post-anesthesia care unit followed by 4-hour intervals once the patient is transferred to the floor. Nurses who are blinded to the analgesic method will evaluate pain levels. Hospital length of stay will be measured from date of admission to date of discharge.

The study drug, Ofiramev® (acetaminophen) injection is a non-salicylate antipyretic and non-opioid analgesic agent. The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. The study drug is a clear, colorless formulation of acetaminophen intended for intravenous infusion and is packaged in glass vials containing 100 mL of 1000 mg acetaminophen (10 mg/mL). The investigational pharmacy will transfer the study drug to a 100 mL bag. The placebo solution will consist of 100 mL normal saline in an identical 100 mL bag with identical labeling. Prior to the induction of anesthesia subjects will receive a single dose of Ofiramev® or placebo by IV infusion over 15 minutes. Following the first dose, each subsequent dose will be given every 6 hours for a total of 4 doses. Regardless of treatment arm, study drug and placebo will be dispensed in the same manner.

Investigational drugs are stored in the investigational drug service storeroom and/or pharmacy satellite depending on the nature of the drug study. All study drug inventory is labeled with IRB identification and stored separately from other commercial drug products under appropriate security and stability conditions. OFIRMEV should be stored at 20°C to 25°C (68°F to 77°F) and should be used within 6 hours after opening.

An accurate and current accounting of the dispensing and return of study drug for each subject will be maintained on an ongoing basis by a member of the study site staff. The number of study drug dispensed and returned by the subject will be recorded on the Investigational Drug Accountability Record. The study monitor will verify these documents throughout the course of the study.

Patients can voluntarily withdraw from the trial for any reason at any time. Subjects will be withdrawn from the study in the event of unplanned conversion to open thoracic surgery or administration of neuraxial opioids. If a subject is withdrawn from treatment due to an adverse event, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Post-thoracotomy Pain Syndrome
Intervention  ICMJE
  • Drug: Ofiramev® (IV Acetaminophen)
    Post -op pain medication
    Other Name: IV Tylenol
  • Drug: Placebo IV administration
    Post -op pain
    Other Name: Normal Saline
Study Arms  ICMJE
  • Active Comparator: Ofiramev®( IV Acetaminophen)
    Patients randomized to the treatment arm will receive 1 g (100 mL) intravenous acetaminophen infused over 15-minutes every 6 hours for 4 doses total.
    Intervention: Drug: Ofiramev® (IV Acetaminophen)
  • Placebo Comparator: Placebo IV administration
    Patients randomized to the placebo arm will receive 100 mL of normal saline infused over 15 minutes every 6 hours for 4 doses total
    Intervention: Drug: Placebo IV administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
100
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-99 years
  • Undergo minimally invasive thoracic surgery at UTMB
  • Weight > 50 kg
  • Written informed consent obtained from subject

Exclusion Criteria:

  • Hepatic dysfunction
  • Renal dysfunction
  • Chronic alcohol consumption
  • Acetaminophen sensitivity
  • Opioid tolerance
  • History of chronic pain
  • Vulnerable populations including pregnant and prisoners
  • Extension into an extrathoracic compartment (i.e. minimally invasive esophagectomy), or concomitant chest wall resection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051932
Other Study ID Numbers  ICMJE 16-0340
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Ikenna Okereke, MD University of Texas Medical Branch at Galveston
PRS Account The University of Texas Medical Branch, Galveston
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP