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

NCT ID: NCT04574791

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

TiZANidine 2 MG Oral Capsule

Intervention Type: DRUG

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

Interventions

TiZANidine 2 MG Oral Capsule

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

MAUS20d635

Identifier Type: -

Identifier Source: org_study_id