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

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: TiZANidine 2 MG Oral Capsule

• Registration Number: NCT04574791
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-03
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal Pain Regimen + Tizanidine	TiZANidine 2 MG Oral Capsule	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

Primary Outcome Measures

Name	Time	Method
opioid consumption (MME) postoperatively	the first 14-days postoperatively	Primary outcome is patients total opioid consumption for the first 14 days after surgery.

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States