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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: TiZANidine 2 MG Oral Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Multimodal Pain Regimen<br>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<br>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<br>* Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen<br>|

What is the study measuring?
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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 |