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

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intravenous Acetaminophen

Placebo (0.9% Normal Saline infusion)

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Pain, Postoperative, Ofirmev, Acetaminophen, Analgesics, Non-Narcotic, Arthroscopy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Florida Hospital Celebration Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous acetaminophen

Placebo (0.9% Normal Saline Infusion)

Arm Description

Infusion of Intravenous acetaminophen (Ofirmev)

Infusion of 100 ml of 0.9 NS Normal Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative Opioid Consumption

To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.

Full Information

NCT ID

NCT02025634

First Posted

December 30, 2013

Last Updated

October 23, 2020

Sponsor

AdventHealth

Collaborators

University of Central Florida

1. Study Identification

Unique Protocol Identification Number

NCT02025634

Brief Title

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

Acronym

IVTYLENOL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AdventHealth

Collaborators

University of Central Florida

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Pain, Postoperative, Ofirmev, Acetaminophen, Analgesics, Non-Narcotic, Arthroscopy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous acetaminophen

Arm Type

Experimental

Arm Description

Infusion of Intravenous acetaminophen (Ofirmev)

Arm Title

Placebo (0.9% Normal Saline Infusion)

Arm Type

Placebo Comparator

Arm Description

Infusion of 100 ml of 0.9 NS Normal Saline

Intervention Type

Drug

Intervention Name(s)

Intravenous Acetaminophen

Other Intervention Name(s)

Ofirmev

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo (0.9% Normal Saline infusion)

Other Intervention Name(s)

Intervention Description

Infusion of 100 ml of 0.9% NS

Primary Outcome Measure Information:

Title

Postoperative Pain Levels

Description

Time Frame

up to 8 hours

Secondary Outcome Measure Information:

Title

Postoperative Opioid Consumption

Description

To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.

Time Frame

up to 8 hours

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

up to 8.6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley Homan, DO

Organizational Affiliation

Florida Hospital Celebration Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Hospital Celebration Health

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

12. IPD Sharing Statement

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

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