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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants undergoing shoulder surgery will be randomized into one of the three study arms.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
participants will be masked to the aspect of post-operative pain management being manipulated in this study; investigator and outcomes assessor will be masked to randomization (group assignment) of participants

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 		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)
    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.
Experimental
Group 2 		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)
    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.
Experimental
Group 3 		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)
    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.

More Details

Status
Completed
Sponsor
Johns Hopkins University

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.