Pain, Postoperative
Conditions
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.
Interventions
DRUGTiZANidine 2 MG Oral Capsule
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption (MME) postoperatively | the first 14-days postoperatively | Primary outcome is patients total opioid consumption for the first 14 days after surgery. |
Countries
United States
Outcome results
None listed