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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: TiZANidine 2 MG Oral Capsule

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Multimodal Pain Regimen; current standard of care post-operative pain regimen in the hospital, which comprises of standing doses of oral acetaminophen 975 mg three times a day, gabapentin 300 mg two times a day, and intravenous ketorolac 30 mg three times a day for patients <65 years and 15 mg IV Q8h for patients who are >65 years, supplemented with PRN oxycodone and tramadol.
Experimental: Multimodal Pain Regimen + Tizanidine; current standard of care post-operative pain regimen in the hospital, which comprises of standing doses of oral acetaminophen 975 mg three times a day, gabapentin 300 mg two times a day, and intravenous ketorolac 30 mg three times a day for patients <65 years and 15 mg IV Q8h for patients who are >65 years, supplemented with PRN oxycodone and tramadol supplemented with standing doses of oral tizanidine in the hospital and for 14 days after discharge	Drug: TiZANidine 2 MG Oral Capsule; Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption (MME) postoperatively	Primary outcome is patients total opioid consumption for the first 14 days after surgery.	the first 14-days postoperatively

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Manifestations; Pain, Postoperative; Muscle Hypotonia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Tizanidine
• Other Study ID Numbers: MAUS20d635

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No