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

Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Intravenous Acetaminophen; Drug: Placebo (0.9% Normal Saline infusion)

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital Celebration Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Levels	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.	up to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Consumption	To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.	up to 8 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")	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.	up to 8.6 hours

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: University of Central Florida
• Investigators: Principal Investigator: Bradley Homan, DO, Florida Hospital Celebration Health

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Acetaminophen; Arthroscopy; Pain, Postoperative; Analgesics, Non-Narcotic; Ofirmev
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 503526