Back to resultsOpioid-Free Orthopaedics
Primary Purpose
Pain, Pain, Postoperative
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxycodone 5 mg Oral Tablet
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain management, Oxycodone
Eligibility Criteria
Inclusion Criteria:
- Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
- Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
- Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
- Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
- Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent
Exclusion Criteria:
- Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
- Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
- Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Sites / Locations
- The Emory ClinicRecruiting
- Emory University HospitalRecruiting
- Emory Orthopedic and Spine HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Opioid Group
Placebo Group
Arm Description
Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Outcomes
Primary Outcome Measures
Change in Pain (VAS) Score
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
Secondary Outcome Measures
Change in patient Satisfaction Scores
Patients will be asked their overall level of satisfaction with the procedure and pain control.
The investigators will use a rating scale with the following choices:
I'm doing MUCH WORSE than I expected
I'm doing SOMEWHAT WORSE than I expected
I'm doing ABOUT THE SAME as I expected
I'm doing SOMEWHAT BETTER than I expected
I'm doing MUCH BETTER than I expected
It is too soon for me to give an opinion
The scale has a maximum value of a patient stating they are doing much better than expected (5) and much worse as the minimum value (1) quantifying the worst outcome. Patients stating it is too soon to give an opinion is a null value.
Change in opioid consumption
The investigators will assess the amount of opioids consumed utilizing total morphine equivalents as an equal metric to compare between patients. It will also de assessed whether the patient utilized he safety/rescue prescription. It will also be included the information on whether patients obtain a refill prescription. Total consumption will be assessed by utilizing total morphine equivalents as the metric as stated previously with patients with higher values quantifying a worse outcome.
Change in associated side effects
The investigators will utilize a 0-10 scale for patient symptoms for feeling any of these side effects due to postoperative medication for the first 14 days and at each follow up visit. We will assess only at each subsequent follow up visit 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months so long as they are continuously taking medications associated with postoperative pain protocol. Outcomes with a score of 10 will quantify a poor result and patients dealing with severe common side effects due to opioid medication.
Change in Single Assessment Numeric Evaluation (SANE) score
The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. The patient will be asked this question at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. A rating of 0 is the minimum value and denotes the lowest possible value and worse outcome a patient can have on the scale.
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
The ASES is a survey designed to assess the condition of the shoulder. This survey will only be utilized in the cases of patients with a shoulder pathology. The survey will utilize the 10 components assessing the activities of daily living. Scores range from 0 to 100 with a score of 0 denoting a worse shoulder condition. The investigators will utilize this assessment at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months.
Change in European Quality of Life 5 dimension (EQ-5D)
The EQ-5D is one of the most commonly used assessments for measuring health and quality of life. The EQ-5D will be assessed at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. The assessment utilizes a scale of 0 to 1 with a score of 0 corresponding to death and 1 representing perfect health.
Length of stay postoperative
The investigators will assess length of stay as another outcome for surgery types that typically require admission to the hospital. It will be assessed this once and collect data with regards to hospital stay following their discharge from the hospital. A shorter time interval corresponds to a better outcome and those patients with a longer stay is a less desirable outcome.
Number of complications
The investigators will assess complications due to surgery such as reoperation, readmission, revision procedure, temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent pain, fractures, and implant loosening and dislocations. The assessment of these complications will happen as they occur and will be recorded as a descriptive and no true values will be recorded rather than the complication itself.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04659317
Brief Title
Opioid-Free Orthopaedics
Official Title
A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.
Detailed Description
Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Postoperative
Keywords
Pain management, Oxycodone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid Group
Arm Type
Active Comparator
Arm Description
Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Arm Title
Placebo Group
Arm Type
Experimental
Arm Description
Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Intervention Type
Drug
Intervention Name(s)
Oxycodone 5 mg Oral Tablet
Intervention Description
Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Encapsulated placebo tablets x24, to take po q6 hours as need for pain
Primary Outcome Measure Information:
Title
Change in Pain (VAS) Score
Description
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
Time Frame
Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Secondary Outcome Measure Information:
Title
Change in patient Satisfaction Scores
Description
Patients will be asked their overall level of satisfaction with the procedure and pain control.
The investigators will use a rating scale with the following choices:
I'm doing MUCH WORSE than I expected
I'm doing SOMEWHAT WORSE than I expected
I'm doing ABOUT THE SAME as I expected
I'm doing SOMEWHAT BETTER than I expected
I'm doing MUCH BETTER than I expected
It is too soon for me to give an opinion
The scale has a maximum value of a patient stating they are doing much better than expected (5) and much worse as the minimum value (1) quantifying the worst outcome. Patients stating it is too soon to give an opinion is a null value.
Time Frame
Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Title
Change in opioid consumption
Description
The investigators will assess the amount of opioids consumed utilizing total morphine equivalents as an equal metric to compare between patients. It will also de assessed whether the patient utilized he safety/rescue prescription. It will also be included the information on whether patients obtain a refill prescription. Total consumption will be assessed by utilizing total morphine equivalents as the metric as stated previously with patients with higher values quantifying a worse outcome.
Time Frame
Baseline, 60 months post operative
Title
Change in associated side effects
Description
The investigators will utilize a 0-10 scale for patient symptoms for feeling any of these side effects due to postoperative medication for the first 14 days and at each follow up visit. We will assess only at each subsequent follow up visit 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months so long as they are continuously taking medications associated with postoperative pain protocol. Outcomes with a score of 10 will quantify a poor result and patients dealing with severe common side effects due to opioid medication.
Time Frame
Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Title
Change in Single Assessment Numeric Evaluation (SANE) score
Description
The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. The patient will be asked this question at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. A rating of 0 is the minimum value and denotes the lowest possible value and worse outcome a patient can have on the scale.
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
Title
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
Description
The ASES is a survey designed to assess the condition of the shoulder. This survey will only be utilized in the cases of patients with a shoulder pathology. The survey will utilize the 10 components assessing the activities of daily living. Scores range from 0 to 100 with a score of 0 denoting a worse shoulder condition. The investigators will utilize this assessment at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months.
Time Frame
baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Title
Change in European Quality of Life 5 dimension (EQ-5D)
Description
The EQ-5D is one of the most commonly used assessments for measuring health and quality of life. The EQ-5D will be assessed at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. The assessment utilizes a scale of 0 to 1 with a score of 0 corresponding to death and 1 representing perfect health.
Time Frame
baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Title
Length of stay postoperative
Description
The investigators will assess length of stay as another outcome for surgery types that typically require admission to the hospital. It will be assessed this once and collect data with regards to hospital stay following their discharge from the hospital. A shorter time interval corresponds to a better outcome and those patients with a longer stay is a less desirable outcome.
Time Frame
End of the trial (up to 60 months post operative)
Title
Number of complications
Description
The investigators will assess complications due to surgery such as reoperation, readmission, revision procedure, temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent pain, fractures, and implant loosening and dislocations. The assessment of these complications will happen as they occur and will be recorded as a descriptive and no true values will be recorded rather than the complication itself.
Time Frame
End of the trial (up to 60 months post operative)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent
Exclusion Criteria:
Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dawes
Phone
404-784-2402
Email
adawes@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Email
eric.r.wagner@emory.edu
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Email
eric.r.wagner@emory.edu
Facility Name
Emory Orthopedic and Spine Hospital
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Email
eric.r.wagner@emory.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid-Free Orthopaedics
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