Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty

Status unconfirmed · Not applicable

Conditions studied: Pain, Postoperative

In brief

This is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary TKA reduces opioid consumption.

Key facts

Study ID

NCT04574791

Run by

Rothman Institute Orthopaedics

People needed

240

Starts

2020-09-03

Expected to finish

2021-09-30

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• - Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
• ASA I - III
• Spinal anesthesia
• All patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. A tourniquet will be used in all cases.
• Men and women between 18 and 80 years who are willing and able to provide informed consent

You may not qualify if…

• Opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively
• Inability to take/allergy to the protocol medications
• Contraindication to regional anesthesia
• Non-English speaking
• ASA IV or greater
• Psychiatric or cognitive disorders
• Allergy/contraindications to protocol medications.
• Renal insufficiency with Cr > 2.0 or hepatic failure
• Sensory/motor disorder involving the operative limb
• PCS score >20
• Patients with severe cardiac or neurological conditions precluding the use of study medications
• Patients using anticoagulation other than aspirin for the 14-day period after discharge

Where it is running

• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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