Skip to main content
OpenTrials
Completed

NCT Number: NCT02025634

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous acetaminophen

Drug

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 names: Ofirmev

Placebo (0.9% Normal Saline infusion)

Drug

Infusion of 100 ml of 0.9% NS

Other names: NS

Primary outcomes

  1. Postoperative Pain Levels

    Time frame: up to 8 hours

    To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.

Secondary outcomes

  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 outcomes

  1. Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")

    Time frame: up to 8.6 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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • University of Central Florida

Registry information

Official study title

Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy

Acronym: IVTYLENOL

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.