The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Completed · Not applicable
Conditions studied: Osteo Arthritis Knee
In brief
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients. PURPOSE: 1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects. 2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
Key facts
- Study ID
- NCT04003350
- Run by
- Rothman Institute Orthopaedics
- People needed
- 216
- Starts
- 2017-12-21
- Expected to finish
- 2019-03-15
- Last updated by the study team
- 2019-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
- Male and Female over 18 who are willing and able to provide informed consent
You may not qualify if…
- Opioid use within 3 months preoperatively
- Inability to take the protocol medications
- Anticoagulant other than aspirin
- 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
- General anesthesia
- Sensory/motor disorder involving the operative limb
Where it is running
- Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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