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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003350
• Other study ID #: 2019MAUSTKA
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: June 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 15, 2019
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Oxycodone
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
• Tramadol
Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
• Tylenol
Tylenol 1000 mg: take as needed every 8 hours
• Meloxicam
Meloxicam 15 mg as need once per day
• Gabapentin
•Gabapentin 200 mg with morning and evening Tylenol dose
• Metaxalone
Metaxalone 800mg TID
• Esomeprazole 20mg
Esomeprazole 20mg daily

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Measured via Visual Analog scale (0-100mm)	Postsurgery days 1-30
Primary	Opioid related side effects	Severity measured via Visual Analog scale (0-100mm)	post-surgery days 1-30
Secondary	opioid consumption	morphine milligram equivalent	post-surgery weeks 1-4
Secondary	opioid consumption	number of pills consumed	post-surgery weeks 1-4
Secondary	number of opioid refills	number of times subjects asked to have an opioid prescription refilled during post-operative period	post-surgery weeks 1-4
Secondary	90 day complications	collection of all post-operative medical complications within the first 90 days after surgery	post-surgery 90 days