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

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04574791
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 18.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: TiZANidine 2 MG Oral Capsule	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
• Actual Study Start Date: Sep 3, 2020
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. opioid consumption (MME) postoperatively [the first 14-days postoperatively]

   Primary outcome is patients total opioid consumption for the first 14 days after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04574791
• Other Study ID Numbers: MAUS20d635
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• 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
• Additional relevant MeSH terms: Muscle Hypotonia; Pain, Postoperative; Tizanidine

Study Results

No Results Posted as of Oct 5, 2020