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

Pain, Postoperative Clinical Trial

— IVTYLENOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025634
• Other study ID #: 503526
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2020
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• Placebo (0.9% Normal Saline infusion)
Infusion of 100 ml of 0.9% NS

Locations

Country	Name	City	State
United States	Florida Hospital Celebration Health	Celebration	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth	University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Postoperative Opioid Consumption	To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.	up to 8 hours