Shoulder PainNCT04622839
Post-Operative Pain Control Following Shoulder Surgery
A study testing Tylenol and NSAIDS (Ibuprofen, diclofenac) in people with Shoulder Pain, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Tylenol and NSAIDS (Ibuprofen, diclofenac)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard County General Hospital
Columbia, Maryland, 21045
About this study
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Tylenol and NSAIDS (Ibuprofen, diclofenac)
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tylenol and NSAIDS (Ibuprofen, diclofenac)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac) |
| Group 2 | Experimental | 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. Receives: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac) |
| Group 3 | Experimental | 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. Receives: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine milligram equivalents (MMEs) consumed
Total possible narcotic pain medication use in MME's
Measured: 2 weeks postop
Opioid Prescription Refills
number and quantity of opioid prescription refills
Measured: 2 weeks postop
Office Contacts
Number of times patient contacted the office via telephone, MyChart, or email
Measured: 2 weeks postop
Secondary outcomes (1)
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
Measured: 2-4 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Dec 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing shoulder surgery will be randomized into one of the three study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Shoulder and Elbow Surgeons
- Responsible party
- Sponsor
- Investigators
- Umasuthan Srikumaran, M.D., Principal investigator, Johns Hopkins Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622839
- Sponsor's protocol ID
- IRB00248454
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain Control Following Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04622839
- Acronym / sponsor ID
- IRB00248454
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Shoulder and Elbow Surgeons
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants undergoing shoulder surgery will be randomized into one of the three study arms.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)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. |
| Group 2 | Experimental | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)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. |
| Group 3 | Experimental | Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Morphine milligram equivalents (MMEs) consumed
Time frame: 2 weeks postop
Total possible narcotic pain medication use in MME's
Opioid Prescription Refills
Time frame: 2 weeks postop
number and quantity of opioid prescription refills
Office Contacts
Time frame: 2 weeks postop
Number of times patient contacted the office via telephone, MyChart, or email
1 secondary outcome
American Shoulder and Elbow Surgeons (ASES) score
Time frame: 2-4 months postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umasuthan Srikumaran, M.D. principal investigator
Johns Hopkins Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tylenol and NSAIDS (Ibuprofen, diclofenac) in people with Shoulder Pain, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine milligram equivalents (MMEs) consumed (time frame: 2 weeks postop). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.