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

Pain, Postoperative research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain, Postoperative

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intravenous AcetaminophenParticipants 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.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous acetaminophenInfusion of Intravenous acetaminophen (Ofirmev)

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

Study Status

Completed

Start Date: November 2013

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Postoperative pain levels

Secondary Outcome: Postoperative opioid consumption

Study sponsors, principal investigator, and references

Principal Investigator: Bradley Homan, DO

Lead Sponsor: Florida Hospital

Collaborator: University of Central Florida

More information:https://clinicaltrials.gov/show/NCT02025634

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