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Post-Operative Pain Control Following Shoulder Surgery

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tylenol and NSAIDS (Ibuprofen, diclofenac)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Howard County General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2020
Last Updated
February 14, 2023
Sponsor
Johns Hopkins University
Collaborators
American Shoulder and Elbow Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT04622839
Brief Title
Post-Operative Pain Control Following Shoulder Surgery
Official Title
Post-Operative Pain Control Following Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
American Shoulder and Elbow Surgeons

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants undergoing shoulder surgery will be randomized into one of the three study arms.
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tylenol and NSAIDS (Ibuprofen, diclofenac)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine milligram equivalents (MMEs) consumed
Description
Total possible narcotic pain medication use in MME's
Time Frame
2 weeks postop
Title
Opioid Prescription Refills
Description
number and quantity of opioid prescription refills
Time Frame
2 weeks postop
Title
Office Contacts
Description
Number of times patient contacted the office via telephone, MyChart, or email
Time Frame
2 weeks postop
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) score
Description
standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function
Time Frame
2-4 months postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umasuthan Srikumaran, M.D.
Organizational Affiliation
Johns Hopkins Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard County General Hospital
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-Operative Pain Control Following Shoulder Surgery

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