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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04574791
• Other study ID #: MAUS20d635
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Hypotonia
• Pain, Postoperative

Intervention

Drug:
• TiZANidine 2 MG Oral Capsule
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption (MME) postoperatively	Primary outcome is patients total opioid consumption for the first 14 days after surgery.	the first 14-days postoperatively