Multimodal Pain Regimen for Rotator Cuff Repair

Overseen By Ferdinand Chan, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Disqualifiers: Alcohol or drug abuse, renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which pain control medications work best for adults after rotator cuff surgery. Participants will receive either a new combination of pain medications (a multimodal pain regimen) or the standard pain treatment currently used. The trial targets adults with a rotator cuff tear that did not improve with regular treatments and are now undergoing surgery. Those who have struggled with shoulder pain and are scheduled for this type of surgery might be suitable candidates for the study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and the trial seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the multimodal pain regimen?

Research has shown that combining different pain relief methods is generally safe and effective for managing pain after surgeries like rotator cuff repairs. These methods help control pain and reduce the need for opioids, which are strong painkillers with potential side effects. One study found that this combined approach can provide the same or even better pain relief than using only opioids.

While safety details can vary for each method, these treatments are commonly used and well-tolerated by patients. By focusing on reducing opioid use, side effects like nausea or dependency may occur less frequently with these combined methods. Overall, evidence suggests that using a combination of pain relief methods is a safe option for managing pain after rotator cuff surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the multimodal pain regimen for rotator cuff repair because it represents a more comprehensive approach to managing pain. Unlike standard pain treatments, which often rely heavily on opioids, this regimen combines various medications that target different pain pathways, potentially reducing the need for opioids and minimizing side effects. By administering these medications at different stages—before, during, and after surgery—the treatment aims to provide more effective and sustained pain relief. This could lead to quicker recovery times and a better overall experience for patients undergoing rotator cuff repair.

What evidence suggests that this trial's treatments could be effective for pain management after rotator cuff surgery?

Research has shown that combining different pain relief methods can better control pain and reduce the need for opioids after surgery. In this trial, participants in the Multimodal Pain Regimen Group will receive such a combination, which studies have found can lead to less pain at rest and noticeable improvement compared to pre-surgery levels. One study discovered that a non-opioid pain plan provided pain relief as good as or even better than traditional opioid medications. Additionally, these plans significantly reduced opioid use after surgery. Overall, evidence supports the effectiveness of using multiple pain relief methods to manage pain after rotator cuff repair. ^{1 2 3 6 7}

Who Is on the Research Team?

Ferdinand Chan, M.D.

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who have a rotator cuff tear that hasn't improved with standard treatments and are now getting arthroscopic repair surgery. It's not for those who can't consent, are pregnant, can't have local nerve blocks, had previous shoulder surgery on the same side, can't take the study drugs due to allergies or other issues, or can't communicate their pain levels.

Inclusion Criteria

I have a rotator cuff tear not improved by basic treatments, needing surgery.

Exclusion Criteria

Patients who are pregnant

I am unable to give consent for the study myself.

I cannot have a local nerve block.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Multimodal pain regimen medications are administered preoperatively in the preoperative holding area

1 day

Intraoperative

Multimodal pain regimen medications are administered during the surgical procedure

1 day

Postoperative

Participants receive either the multimodal pain regimen or the standard pain regimen postoperatively

7 days

Follow-up

Participants are monitored for pain intensity and narcotics usage post-surgery

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Pain Regimen

Trial Overview The study compares two types of pain control methods after rotator cuff surgery: the usual care versus a multimodal approach. The aim is to find out which one reduces the need for narcotics more effectively in managing post-surgery pain.

How Is the Trial Designed?

Group I: Multimodal Pain Regimen Group Experimental Treatment 1 Intervention

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.

Group II: Standard Pain Regimen Group Active Control 1 Intervention

Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9042766/

Postoperative Multimodal Pain Management and Opioid ... Many multimodal pain management protocols offer improved pain control and decreased opioid consumption after arthroscopic surgery.

2. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00444-4/fulltext

Multimodal Analgesia for Rotator Cuff Repair Should Be ... After 2 weeks, the N group still had less pain at rest and a significant improvement in pain compared with the preoperative state in comparison ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074980632101046X

Multimodal Nonopioid Pain Protocol Provides Better or ... The present study found that a multimodal nonopioid pain protocol provided equivalent or better pain control compared to traditional opioid analgesics.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2796947

Effect of Opioid-Sparing Protocol vs Standard Prescribing ... A multimodal opioid-sparing postoperative pain protocol, compared with standard opioid prescribing, significantly reduced postoperative opioid consumption over ...

5. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1401&context=orthopaedics_articles

Multimodal Nonopioid Pain Protocol Provides Better or ... Concussion: The present study found that a multimodal nonopioid pain protocol provided equivalent or better pain control compared to traditional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07076069

The Effect of Multimodal Pain Regimen on Use of Narcotics ... 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.

7. jsesinternational.org jsesinternational.org/article/S2666-6383(21)00059-1/fulltext

An integrated educational and multimodal approach to ... The purpose of this study was to evaluate effectiveness of preoperative and postoperative patient education and multimodal pain management to achieve an opioid ...