Rotator Cuff RepairsPhase 4NCT07076069
The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
A Phase 4 study testing Multimodal Pain Regimen in people with Rotator Cuff Repairs and Pain Management, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Repairs, Pain Management
- What is being tested?
- Multimodal Pain Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults with rotator cuff tears who have failed conservative therapy and are now undergoing arthroscopic rotator cuff repair.
Who cannot join
- Patients without capacity to consent for the study
- Patients not able to have local nerve block
- Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair
- Patients who are unable to record and verbalize their pain level due to altered mental status
- Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication
- Patients with history of previously diagnosed alcohol or drug abuse, renal impairment, peptic ulcer disease, and gastrointestinal bleeding
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Hutchinson Campus
The Bronx, New York, 10461
Ferdinand Chan, M.D., 718-920-2060, fchan@montefiore.org
About this study
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
Read the detailed description
The purpose of this study is to investigate whether a previously described multimodal pain protocol involving non-narcotic medications compared to the medical center's current postoperative pain regimen mainly involving narcotics will decrease total rescue narcotics used for patients who undergo arthroscopic rotator cuff tear repair at Montefiore. The implications of the study would be reduced narcotics consumptions in postoperative patients and improved self-reported patient outcomes. Through this study, the investigator team hopes to develop a pain regimen that alleviates dependence on opioids in postoperative patients without sacrificing patient satisfaction and comfort.
- Conditions
- Rotator Cuff Repairs, Pain Management
- Being tested
- Multimodal Pain Regimen, Standard of Care Pain Regimen
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Pain RegimenDrug
Preoperatively: One dose of Pregabalin 100mg and Celecoxib 400mg along with interscalene block
Intraoperatively: Intravenous Dexamethasone 0.1mg/kg (maximum dose of 8mg), Magnesium 2g, Acetaminophen 1000mg, and local infiltration of 0.5% Ropivacaine 20ml
Postoperatively (Discharge): Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed
Standard of Care Pain RegimenDrug
No preoperative medications. Interscalene block in the preoperative holding area. Alternating Acetaminophen 975mg and Ibuprofen 600mg every 4 hours, with rescue Oxycodone 5mg every 4 hours, as needed
| Study group | Role | What they receive |
|---|---|---|
| Standard Pain Regimen Group | Active comparator | Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description. Receives: Drug: Standard of Care Pain Regimen |
| Multimodal Pain Regimen Group | Experimental | Multimodal pain regimen medications will be prescribed and administered preoperatively in preoperative holding area, intraoperatively during the procedure, and postoperatively as described in the Intervention Description. Receives: Drug: Multimodal Pain Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative narcotics usage
Post-operative narcotics usage will be assessed by the number of oxycodone tablets used in the first week (7 days) after surgery. The week's use will be accounted by counting the left-over oxycodone tablets brought in by the patients. In addition, the electronic medical record will be checked to ensure that no extra narcotics were called in. Results will be summarized by study arm using means and standard deviations.
Measured: Post-operative day 7
Pain Score using the Visual Analogue Scale (VAS)
A pain score will be determined using the VAS, a unidimensional measure of pain intensity. Patients will be asked to rate and record pain intensity daily during the study. The VAS score at post-operative day 7 will be reported. The VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100, such that higher scores are indicative of greater pain intensity. Results will be summarized by study arm using basic descriptive statistics.
Measured: Post-operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2025
- Study start21 Jul 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff RepairsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before surgeries, patients will be assigned to one of the two arms in a block randomization fashion in a 1:1 ratio. A block randomization scheme with a block size of 6 will be generated and maintained by the study statistician.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferdinand Chan, M.D., Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076069
- Sponsor's protocol ID
- 2022-14249
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones MR, Viswanath O, Peck J, Kaye AD, Gill JS, Simopoulos TT. A Brief History of the Opioid Epidemic and Strategies for Pain Medicine. Pain Ther. 2018 Jun;7(1):13-21. doi: 10.1007/s40122-018-0097-6. Epub 2018 Apr 24.
PubMed 29691801Storesund A, Krukhaug Y, Olsen MV, Rygh LJ, Nilsen RM, Norekval TM. Females report higher postoperative pain scores than males after ankle surgery. Scand J Pain. 2016 Jul;12:85-93. doi: 10.1016/j.sjpain.2016.05.001. Epub 2016 May 27.
PubMed 28850501Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
PubMed 29049117Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
PubMed 32353620
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
- ClinicalTrials.gov ID
- NCT07076069
- Acronym / sponsor ID
- 2022-14249
- Conditions
- Rotator Cuff Repairs, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Jul 2025 (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.
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
Detailed description
The purpose of this study is to investigate whether a previously described multimodal pain protocol involving non-narcotic medications compared to the medical center's current postoperative pain regimen mainly involving narcotics will decrease total rescue narcotics used for patients who undergo arthroscopic rotator cuff tear repair at Montefiore. The implications of the study would be reduced narcotics consumptions in postoperative patients and improved self-reported patient outcomes. Through this study, the investigator team hopes to develop a pain regimen that alleviates dependence on opioids in postoperative patients without sacrificing patient satisfaction and comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before surgeries, patients will be assigned to one of the two arms in a block randomization fashion in a 1:1 ratio. A block randomization scheme with a block size of 6 will be generated and maintained by the study statistician.
| Arm | Type | Receives |
|---|---|---|
| Standard Pain Regimen Group | Active comparator | Drug: Standard of Care Pain RegimenPatients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description. |
| Multimodal Pain Regimen Group | Experimental | Drug: Multimodal Pain RegimenMultimodal pain regimen medications will be prescribed and administered preoperatively in preoperative holding area, intraoperatively during the procedure, and postoperatively as described in the Intervention Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with rotator cuff tears who have failed conservative therapy and are now undergoing arthroscopic rotator cuff repair.
Key exclusion criteria (7 listed)
- Patients without capacity to consent for the study
- Patients not able to have local nerve block
- Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair
- Patients who are unable to record and verbalize their pain level due to altered mental status
- Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication
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 |
|---|---|---|
| Multimodal Pain RegimenPreoperatively: One dose of Pregabalin 100mg and Celecoxib 400mg along with interscalene block Intraoperatively: Intravenous Dexamethasone 0.1mg/kg (maximum dose of 8mg), Magnesium 2g, Acetaminophen 1000mg, and local infiltration of 0.5% Ropivacaine 20ml Postoperatively (Discharge): Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed | Drug | Multimodal Pain Regimen Group |
| Standard of Care Pain RegimenNo preoperative medications. Interscalene block in the preoperative holding area. Alternating Acetaminophen 975mg and Ibuprofen 600mg every 4 hours, with rescue Oxycodone 5mg every 4 hours, as needed | Drug | Standard Pain Regimen Group |
Primary outcome
Post-operative narcotics usage
Time frame: Post-operative day 7
Post-operative narcotics usage will be assessed by the number of oxycodone tablets used in the first week (7 days) after surgery. The week's use will be accounted by counting the left-over oxycodone tablets brought in by the patients. In addition, the electronic medical record will be checked to ensure that no extra narcotics were called in. Results will be summarized by study arm using means and standard deviations.
Pain Score using the Visual Analogue Scale (VAS)
Time frame: Post-operative day 7
A pain score will be determined using the VAS, a unidimensional measure of pain intensity. Patients will be asked to rate and record pain intensity daily during the study. The VAS score at post-operative day 7 will be reported. The VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100, such that higher scores are indicative of greater pain intensity. Results will be summarized by study arm using basic descriptive statistics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 29691801Jones MR, Viswanath O, Peck J, Kaye AD, Gill JS, Simopoulos TT. A Brief History of the Opioid Epidemic and Strategies for Pain Medicine. Pain Ther. 2018 Jun;7(1):13-21. doi: 10.1007/s40122-018-0097-6. Epub 2018 Apr 24.
- Background: PubMed 28850501Storesund A, Krukhaug Y, Olsen MV, Rygh LJ, Nilsen RM, Norekval TM. Females report higher postoperative pain scores than males after ankle surgery. Scand J Pain. 2016 Jul;12:85-93. doi: 10.1016/j.sjpain.2016.05.001. Epub 2016 May 27.
- Background: PubMed 29049117Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
- Background: PubMed 32353620Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
- 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.
Ferdinand Chan, M.D. principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multimodal Pain Regimen in people with Rotator Cuff Repairs and Pain Management, run by Montefiore Medical Center 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferdinand Chan, M.D. (718-920-2060, fchan@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative narcotics usage (time frame: Post-operative day 7). 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 NCT07076069, which also lists 4 linked publications.
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 13 Jul 2026.