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

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Drug: Oxycodone; Drug: Tramadol; Drug: Tylenol; Drug: Meloxicam; Drug: Gabapentin; Drug: Metaxalone; Drug: Esomeprazole 20mg

• Registration Number: NCT04003350
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Primary Completion: 2018-11-26
• Study Completion: 2019-03-15
• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-27
• Last Update Submitted: 2019-06-27
• Study First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Regimen	Oxycodone	Weeks 1-4 * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets)
Multimodal pain regimen with PRN opioids	Esomeprazole 20mg	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)
Multimodal pain regimen with PRN opioids	Oxycodone	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)
Multimodal pain regimen with PRN opioids	Meloxicam	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)
Opioid Regimen	Tramadol	Weeks 1-4 * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets)
Multimodal pain regimen with PRN opioids	Tramadol	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)
Multimodal pain regimen with PRN opioids	Tylenol	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)
Multimodal pain regimen with PRN opioids	Gabapentin	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)
Multimodal pain regimen with PRN opioids	Metaxalone	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)

Primary Outcome Measures

Name	Time	Method
Opioid related side effects	post-surgery days 1-30	Severity measured via Visual Analog scale (0-100mm)
Post-operative pain	Postsurgery days 1-30	Measured via Visual Analog scale (0-100mm)

Secondary Outcome Measures

Name	Time	Method
90 day complications	post-surgery 90 days	collection of all post-operative medical complications within the first 90 days after surgery
number of opioid refills	post-surgery weeks 1-4	number of times subjects asked to have an opioid prescription refilled during post-operative period
opioid consumption	post-surgery weeks 1-4	number of pills consumed

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States