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

NCT04574791 | Unknown

• 1 other identifier: MAUS20d635
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• opioid consumption (MME) postoperatively

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

  the first 14-days postoperatively

Study Arms (2)

Multimodal Pain Regimen

NO INTERVENTION

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.

Multimodal Pain Regimen + Tizanidine

EXPERIMENTAL

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

Interventions

TiZANidine 2 MG Oral Capsule DRUG

Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen

Multimodal Pain Regimen + Tizanidine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: September 3, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

US (1)