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

NCT04003350 | Completed

• 1 other identifier: 2019MAUSTKA
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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. 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. 2.To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Post-operative pain

  Measured via Visual Analog scale (0-100mm)

  Postsurgery days 1-30

• Opioid related side effects

  Severity measured via Visual Analog scale (0-100mm)

  post-surgery days 1-30

Secondary Outcomes (4)

• opioid consumption

  post-surgery weeks 1-4

• opioid consumption

  post-surgery weeks 1-4

• number of opioid refills

  post-surgery weeks 1-4

• 90 day complications

  post-surgery 90 days

Study Arms (2)

Opioid Regimen

ACTIVE COMPARATOR

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

Drug: Oxycodone; Drug: Tramadol

Multimodal pain regimen with PRN opioids

EXPERIMENTAL

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)

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

Interventions

Oxycodone DRUG

Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)

Multimodal pain regimen with PRN opioids; Opioid Regimen

Tramadol DRUG

Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)

Multimodal pain regimen with PRN opioids; Opioid Regimen

Tylenol DRUG

Tylenol 1000 mg: take as needed every 8 hours

Multimodal pain regimen with PRN opioids

Meloxicam DRUG

Meloxicam 15 mg as need once per day

Multimodal pain regimen with PRN opioids

Gabapentin DRUG

•Gabapentin 200 mg with morning and evening Tylenol dose

Multimodal pain regimen with PRN opioids

Metaxalone DRUG

Metaxalone 800mg TID

Multimodal pain regimen with PRN opioids

Esomeprazole 20mg DRUG

Esomeprazole 20mg daily

Multimodal pain regimen with PRN opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Location

Related Publications (1)

• Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30.

  PMID: 33036845 DERIVED

MeSH Terms

Interventions

Oxycodone; Tramadol; Acetaminophen; Meloxicam; Gabapentin; metaxalone; Esomeprazole

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Thiazines; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: July 1, 2019
• Study Start: December 21, 2017
• Primary Completion: November 26, 2018
• Study Completion: March 15, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

US (1)