Post-Operative Pain Control Following Shoulder Surgery

• ClinicalTrials.gov Identifier: NCT04622839
• Recruitment Status: Recruiting
• First Posted: November 10, 2020
• Last Update Posted: December 9, 2021
• Sponsor: Johns Hopkins University
• Collaborator: American Shoulder and Elbow Surgeons
• Information provided by (Responsible Party): Johns Hopkins University

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain	Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)	Not Applicable

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 and non-narcotic analgesic use following surgical treatment for shoulder pathology.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants (stratified into five surgical categories) will be randomized into one of the three study arms.
• 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
• Primary Purpose: Treatment
• Official Title: Post-Operative Pain Control Following Shoulder Surgery
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: June 7, 2022
• Estimated Study Completion Date: June 7, 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 24 hours postop ]
   Total narcotic pain medication use in MME's
2. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 48 hours postop ]
   Total narcotic pain medication use in MME's
3. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 72 hours postop ]
   Total narcotic pain medication use in MME's
4. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 7-14 days postop ]
   Total narcotic pain medication use in MME's
5. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 4-6 weeks postop ]
   Total narcotic pain medication use in MME's
6. Morphine milligram equivalents (MMEs) consumed [ Time Frame: 10-14 weeks postop ]
   Total narcotic pain medication use in MME's
7. Numeric Pain Rating Scale [ Time Frame: 24 hours post op ]
   0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
8. Numeric Pain Rating Scale [ Time Frame: 48 hours post op ]
   0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
9. Numeric Pain Rating Scale [ Time Frame: 72 hours post op ]
   0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
10. Numeric Pain Rating Scale [ Time Frame: 7-14 days post-op ]
    0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
11. Numeric Pain Rating Scale [ Time Frame: 4-6 weeks post-op ]
    0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
12. Numeric Pain Rating Scale [ Time Frame: 10-14 weeks post-op ]
    0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
13. Length of time to stop opioid use [ Time Frame: Up to 14 weeks postop ]
    Length of time (days) to completely stop opioid use after surgery.
14. Amount of unused opioid medication in MMEs [ Time Frame: Up to 14 weeks postop ]
    Total amount of MMEs leftover from post-operative pain prescriptions after stopping opioid use.
15. Number of medication refill requests [ Time Frame: Up to 14 weeks postop ]
    Total number of calls or electronic requests by participant requesting additional pain medication.
16. Knowledge of opioid storage and disposal [ Time Frame: Up to 14 weeks postop ]
    Knowledge and practice of safe opioid storage and disposal procedures as assessed by a 6-item questionnaire
17. Patient satisfaction with postoperative pain management [ Time Frame: 24 hours post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
18. Patient satisfaction with postoperative pain management [ Time Frame: 48 hours post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
19. Patient satisfaction with postoperative pain management [ Time Frame: 72 hours post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
20. Patient satisfaction with postoperative pain management [ Time Frame: 7-14 days post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
21. Patient satisfaction with postoperative pain management [ Time Frame: 4-6 weeks post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
22. Patient satisfaction with postoperative pain management [ Time Frame: 10-14 weeks post-op ]
    0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
23. Non-medication analgesic methods [ Time Frame: 24 hours post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
24. Non-medication analgesic methods [ Time Frame: 48 hours post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
25. Non-medication analgesic methods [ Time Frame: 72 hours post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
26. Non-medication analgesic methods [ Time Frame: 7-14 hours post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
27. Non-medication analgesic methods [ Time Frame: 4-6 weeks post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
28. Non-medication analgesic methods [ Time Frame: 10-14 weeks post-op ]
    6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.

Secondary Outcome Measures :

1. American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: 7-14 days postop ]
   standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function
2. American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: 10-14 weeks postop ]
   standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function
3. Comprehensive Shoulder Assessment score [ Time Frame: 7-14 days postop ]
   6 item questionnaire to asses shoulder-specific quality-of-life; score range 0-100 with higher score reflecting higher shoulder-specific quality-of-life
4. Comprehensive Shoulder Assessment score [ Time Frame: 10-14 weeks postop ]
   6 item questionnaire to asses shoulder-specific quality-of-life; score range 0-100 with higher score reflecting higher shoulder-specific quality-of-life

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Saisanjana Vattigunta; 4435461550; svattig1@jhmi.edu

Contact: Sabrina Jenkins; sjenki43@jhmi.edu

Locations

United States, Maryland

Howard County General Hospital; Recruiting

Columbia, Maryland, United States, 21045

Contact: Mehro Akhtar 443-546-1402

Sponsors and Collaborators

Johns Hopkins University

American Shoulder and Elbow Surgeons

Investigators

• Principal Investigator: Umasuthan Srikumaran, M.D.; Johns Hopkins Orthopedics

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04622839
• Other Study ID Numbers: IRB00248454
• First Posted: November 10, 2020
• Last Update Posted: December 9, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Shoulder Pain; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Acetaminophen; Ibuprofen; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antipyretics