Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

Completed · Phase 4

Conditions studied: Unilateral Knee Arthroplasty

In brief

This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.

Key facts

Study ID

NCT02449369

Run by

AdventHealth

People needed

180

Starts

2015-04-01

Expected to finish

2016-09-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-85
• Primary, unilateral total knee arthroplasty
• American Society of Anesthesiologist (ASA) physical status I, II, or III

You may not qualify if…

• Chronic pain (as determined by regular opioid use in the month preceding surgery)
• Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
• Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
• Severe renal dysfunction, creatinine > 2.0
• Allergy or other contraindications to use of orphenadrine and/or acetaminophen
• Pregnant or breast feeding
• Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
• History of Hepatitis, B or C,
• History of cirrhosis or hepatic insufficiency

Where it is running

• Florida Hospital Winter Park — Winter Park, Florida, United States

Full record on ClinicalTrials.gov

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