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

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Tramadol
Tylenol
Meloxicam
Gabapentin
Metaxalone
Esomeprazole 20mg
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Opioid Regimen

Multimodal pain regimen with PRN opioids

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Post-operative pain
Measured via Visual Analog scale (0-100mm)
Opioid related side effects
Severity measured via Visual Analog scale (0-100mm)

Secondary Outcome Measures

opioid consumption
morphine milligram equivalent
opioid consumption
number of pills consumed
number of opioid refills
number of times subjects asked to have an opioid prescription refilled during post-operative period
90 day complications
collection of all post-operative medical complications within the first 90 days after surgery

Full Information

First Posted
June 21, 2019
Last Updated
June 27, 2019
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04003350
Brief Title
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Official Title
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid Regimen
Arm Type
Active Comparator
Arm Description
Weeks 1-4 Oxycodone 5 mg PRN q4h (30 tablets) Tramadol 50 mg PRN q6h (30 tablets)
Arm Title
Multimodal pain regimen with PRN opioids
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
Intervention Type
Drug
Intervention Name(s)
Tylenol
Intervention Description
Tylenol 1000 mg: take as needed every 8 hours
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
Meloxicam 15 mg as need once per day
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
•Gabapentin 200 mg with morning and evening Tylenol dose
Intervention Type
Drug
Intervention Name(s)
Metaxalone
Intervention Description
Metaxalone 800mg TID
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20mg
Intervention Description
Esomeprazole 20mg daily
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Measured via Visual Analog scale (0-100mm)
Time Frame
Postsurgery days 1-30
Title
Opioid related side effects
Description
Severity measured via Visual Analog scale (0-100mm)
Time Frame
post-surgery days 1-30
Secondary Outcome Measure Information:
Title
opioid consumption
Description
morphine milligram equivalent
Time Frame
post-surgery weeks 1-4
Title
opioid consumption
Description
number of pills consumed
Time Frame
post-surgery weeks 1-4
Title
number of opioid refills
Description
number of times subjects asked to have an opioid prescription refilled during post-operative period
Time Frame
post-surgery weeks 1-4
Title
90 day complications
Description
collection of all post-operative medical complications within the first 90 days after surgery
Time Frame
post-surgery 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33036845
Citation
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.
Results Reference
derived

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

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