Overview
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2021-09-30
2021-09-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Rothman Institute OrthopaedicsTreatments:
Tizanidine
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