Post-Operative Pain Control Following Shoulder Surgery

Study Overview
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Brief Summary
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This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

Detailed Description
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There is currently very limited information in the literature regarding postoperative pain medication consumption following orthopedic shoulder surgery. To fill this knowledge gap, this study will evaluate overall opioid consumption in morphine milligram equivalents following surgical treatment for shoulder pathology.

Official Title
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Post-Operative Pain Control Following Shoulder Surgery

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Opioid-naive adults age 18-90 years old planning to undergo surgical treatment for shoulder pathology with the PI at Johns Hopkins Shoulder Service (Columbia, Odenton clinic sites; Howard County General Hospital/Johns Hopkins Hospital operative sites) will be included. Exclusion Criteria: Patients with prior history of opioid misuse, addiction, or chronic pain Patients taking chronic pain medication or have taken opioid medication in the past 3 months will be excluded due to risk of developing drug tolerances that could affect the amount of pain medication consumed after surgery An exception will be made for those who have used narcotic medication for fracture-related events, and expect to undergo surgical treatment for fracture repair (ORIF or arthroplasty) Patients with BMI < 18.5 or > 39.9 Patients with a history of adverse reaction and/or allergy to oxycodone Patients lacking the ability to consent will also be excluded. Patients whose primary residence is outside the United States will be excluded. Patients who are unable to complete questionnaires due to medical condition, psychiatric illness, or significant language barrier will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants undergoing shoulder surgery will be randomized into one of the three study arms.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc. | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)<br>* This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below): Agents used in nerve block (lidocaine vs ropivacaine) Location of injection for analgesic Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.) Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.) Number of pills in the initial opioid prescription Instructions for sling wear (duration of use or type of sling) Ice usage (duration of use and frequency of use) Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.<br>|
| Experimental: Group 2<br>Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc. | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)<br>* This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below): Agents used in nerve block (lidocaine vs ropivacaine) Location of injection for analgesic Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.) Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.) Number of pills in the initial opioid prescription Instructions for sling wear (duration of use or type of sling) Ice usage (duration of use and frequency of use) Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.<br>|
| Experimental: Group 3<br>Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc. | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)<br>* This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below): Agents used in nerve block (lidocaine vs ropivacaine) Location of injection for analgesic Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.) Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.) Number of pills in the initial opioid prescription Instructions for sling wear (duration of use or type of sling) Ice usage (duration of use and frequency of use) Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine milligram equivalents (MMEs) consumed | Total possible narcotic pain medication use in MME's | 2 weeks postop | 
| Opioid Prescription Refills | number and quantity of opioid prescription refills | 2 weeks postop | 
| Office Contacts | Number of times patient contacted the office via telephone, MyChart, or email | 2 weeks postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons (ASES) score | standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function | 2-4 months postop |