Shoulder PainNCT04018768
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
An observational study of Shoulder Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- ibuprofen 600 mg and Oxycodone/acetaminophen (Percocet) 5 mg/325
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Feb 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for isolated arthroscopic shoulder instability surgery
Who may be able to join
- ASA class I-II
- Patients scheduled for arthroscopic shoulder instability surgery
Who cannot join
- Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age or older than 65
- Any patient considered a vulnerable subject
- Patients on pain medication prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.
- Conditions
- Shoulder Pain
- Being tested
- ibuprofen 600 mg, Oxycodone/acetaminophen (Percocet) 5 mg/325
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen 600 mgOther
MRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen.
Oxycodone/acetaminophen (Percocet) 5 mg/325Other
MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen + Percocet | Not described Receives: Other: ibuprofen 600 mg; Other: Oxycodone/acetaminophen (Percocet) 5 mg/325 | |
| Percocet | Not described Receives: Other: Oxycodone/acetaminophen (Percocet) 5 mg/325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Score
Scale consisting of a drawn line from 0 to 100 - the patient will be asked to mark where they believe their pain is (100 being worse pain).
Measured: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Change in Verbal Rating Scale (VRS)
Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)
Measured: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Dec 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirk Campbell, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018768
- Sponsor's protocol ID
- 17-01177
- Status last verified
- May 2020
- First submitted
- 29 May 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Preoperative Opioid Education has No Effect on Opioid Use in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Clinical Trial. J Am Acad Orthop Surg. 2021 Oct 1;29(19):e961-e968. doi: 10.5435/JAAOS-D-20-00594.
PubMed 33306558
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
- ClinicalTrials.gov ID
- NCT04018768
- Acronym / sponsor ID
- 17-01177
- Conditions
- Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 12 Jul 2019 (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 will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen + Percocet | – | Other: ibuprofen 600 mg, Other: Oxycodone/acetaminophen (Percocet) 5 mg/325 |
| Percocet | – | Other: Oxycodone/acetaminophen (Percocet) 5 mg/325 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for isolated arthroscopic shoulder instability surgery
Key inclusion criteria (2 listed)
- ASA class I-II
- Patients scheduled for arthroscopic shoulder instability surgery
Key exclusion criteria (5 listed)
- Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age or older than 65
- Any patient considered a vulnerable subject
- Patients on pain medication prior to surgery
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 |
|---|---|---|
| ibuprofen 600 mgMRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen. | Other | Ibuprofen + Percocet |
| Oxycodone/acetaminophen (Percocet) 5 mg/325MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN. | Other | Ibuprofen + Percocet, Percocet |
Primary outcome
Change in Visual Analog Scale (VAS) Score
Time frame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Scale consisting of a drawn line from 0 to 100 - the patient will be asked to mark where they believe their pain is (100 being worse pain).
Change in Verbal Rating Scale (VRS)
Time frame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)
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 29 May 2020.
- Derived from this study: PubMed 33306558Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Preoperative Opioid Education has No Effect on Opioid Use in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Clinical Trial. J Am Acad Orthop Surg. 2021 Oct 1;29(19):e961-e968. doi: 10.5435/JAAOS-D-20-00594.
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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.
Kirk Campbell principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by NYU Langone Health 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 2 inclusion and 5 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 29 May 2020. 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?
Change in Visual Analog Scale (VAS) Score (time frame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018768, which also lists 1 linked publication.
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 29 May 2020.