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

NCT ID: NCT04003350

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2019-03-15

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opioid Regimen

Weeks 1-4

• Oxycodone 5 mg PRN q4h (30 tablets)
• Tramadol 50 mg PRN q6h (30 tablets)

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

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

Tramadol

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

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

Tramadol

Intervention Type: DRUG

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

Tylenol

Intervention Type: DRUG

Tylenol 1000 mg: take as needed every 8 hours

Meloxicam

Intervention Type: DRUG

Meloxicam 15 mg as need once per day

Gabapentin

Intervention Type: DRUG

•Gabapentin 200 mg with morning and evening Tylenol dose

Metaxalone

Intervention Type: DRUG

Metaxalone 800mg TID

Esomeprazole 20mg

Intervention Type: DRUG

Esomeprazole 20mg daily

Interventions

Oxycodone

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

Intervention Type: DRUG

Tramadol

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

Intervention Type: DRUG

Tylenol

Tylenol 1000 mg: take as needed every 8 hours

Intervention Type: DRUG

Meloxicam

Meloxicam 15 mg as need once per day

Intervention Type: DRUG

Gabapentin

•Gabapentin 200 mg with morning and evening Tylenol dose

Intervention Type: DRUG

Metaxalone

Metaxalone 800mg TID

Intervention Type: DRUG

Esomeprazole 20mg

Esomeprazole 20mg daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Institute

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33036845 (View on PubMed)

Other Identifiers

2019MAUSTKA

Identifier Type: -

Identifier Source: org_study_id