Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy (IVTYLENOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025634
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
University of Central Florida
Information provided by (Responsible Party):
Florida Hospital

Brief Summary:
The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Intravenous Acetaminophen Drug: Placebo (0.9% Normal Saline infusion) Phase 4

Detailed Description:

This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).

The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous acetaminophen
Infusion of Intravenous acetaminophen (Ofirmev)
Drug: Intravenous Acetaminophen
Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
Other Name: Ofirmev

Placebo Comparator: Placebo (0.9% Normal Saline Infusion)
Infusion of 100 ml of 0.9 NS Normal Saline
Drug: Placebo (0.9% Normal Saline infusion)
Infusion of 100 ml of 0.9% NS
Other Name: NS




Primary Outcome Measures :
  1. Postoperative pain levels [ Time Frame: up to 8 hours ]
    To determine if postoperative pain levels, as measured by a VNRS, are reduced with the administration of IV acetaminophen when compared to a control group


Secondary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: up to 8 hours ]
    To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.


Other Outcome Measures:
  1. Total time in PACU [ Time Frame: up to 8 hours ]
    To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is scheduled for knee arthroscopy with or without chondroplasty.
  • Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
  • Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
  • Is willing and able to sign an informed consent.

Exclusion Criteria:

  • Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
  • Has self-reported and/or documented previous hypersensitivity to acetaminophen.
  • Has self-reported and/or documented history of hepatic disease or impairment.
  • Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
  • Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
  • Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025634


Locations
Layout table for location information
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
Sponsors and Collaborators
Florida Hospital
University of Central Florida
Investigators
Layout table for investigator information
Principal Investigator: Bradley Homan, DO Florida Hospital Celebration Health

Layout table for additonal information
Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT02025634     History of Changes
Other Study ID Numbers: 503526
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Florida Hospital:
Pain, Postoperative
Ofirmev
Acetaminophen
Analgesics, Non-Narcotic
Arthroscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics