The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Rothman Institute Orthopaedics

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Drug: Gabapentin; Drug: Tylenol; Drug: Oxycodone; Drug: Metaxalone; Drug: Tramadol; Drug: Meloxicam; Drug: Esomeprazole 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04003350

2019MAUSTKA

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Opioid Regimen

Active Comparator group

Description:

Weeks 1-4 * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets)

Treatment:

Drug: Tramadol

Drug: Oxycodone

Multimodal pain regimen with PRN opioids

Experimental group

Description:

Weeks 1-4 * Tylenol 1000 mg q8h (standing) * Meloxicam 15 mg qD (standing). * Gabapentin 200 mg BID (with morning and evening Tylenol dose) * Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone) * Esomeprazole 20mg daily if not already on another H2 blocker or PPI * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets)

Treatment:

Drug: Metaxalone

Drug: Gabapentin

Drug: Tylenol

Drug: Tramadol

Drug: Meloxicam

Drug: Esomeprazole 20mg

Drug: Oxycodone