Opioid-Free Pain Protocol for Shoulder Surgery

Overseen By Stephanie J Muh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Henry Ford Health System

Must not be taking: Blood thinners, Narcotics

Disqualifiers: Alcohol abuse, Pregnancy, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after shoulder surgery without opioids. Researchers will compare two groups: one using a mix of non-opioid painkillers (the Opioid-Free Pain Protocol) and the other using the same mix plus a standard opioid medication. The goal is to determine if both methods provide similar pain relief in the first 10 days post-surgery. Individuals scheduled for shoulder replacement surgery, without a history of narcotic use or certain medical conditions, might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients, contributing to broader pain management solutions.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using blood thinners or have a history of narcotic use within 3 months prior to surgery, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use blood thinners or have a history of narcotic use within 3 months before surgery.

What is the safety track record for this treatment?

Research has shown that a pain management plan without opioids for shoulder surgery is generally well-tolerated by patients. Studies have found that using a combination of different non-opioid medications does not lead to severe side effects, suggesting safety for those undergoing shoulder replacement surgery. Additionally, this method aims to control pain effectively while avoiding the risks of opioid use, such as addiction. Overall, evidence supports this plan as a safe option for managing pain without opioids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an opioid-free pain management protocol for shoulder surgery, which could significantly reduce the reliance on narcotics like oxycodone. This alternative approach uses a combination of non-narcotic medications such as Celecoxib, Pregabalin, Tramadol, and Tizanidine, aiming to manage pain effectively without the risk of opioid dependency. Additionally, the protocol includes local anesthetics like Ropivacaine and anti-inflammatories like Dexamethasone and Ketorolac, which may provide targeted pain relief with fewer systemic side effects. By potentially offering a safer pain management option, this trial could pave the way for more sustainable post-surgical recovery practices.

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

This trial will compare two different pain management protocols for shoulder surgery. Research has shown that combining various pain management methods can reduce opioid use. In this trial, one group will follow a Multimodal, Non-Narcotic protocol, providing pain relief without opioid-containing medications. Studies have found that these methods can offer sufficient pain relief without opioids. In one study, patients who avoided opioids experienced similar pain relief to those who used them. Another group in this trial will follow a Multimodal Plus Narcotic protocol, which includes opioids as needed. Specifically, one study showed that nearly half of the patients stopped using opioids entirely within two weeks after surgery. This suggests that managing pain without opioids can be as effective as using them after shoulder surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for shoulder arthroplasty at a Henry Ford hospital who can communicate via text and understand English. They must not have allergies to study medications, recent narcotic use, gastrointestinal bleeding, liver or kidney issues, substance abuse problems, current/recent pregnancy, or be on blood thinners.

Inclusion Criteria

I am scheduled for shoulder replacement surgery at a Henry Ford hospital.

Exclusion Criteria

I cannot send or receive text messages on my phone.

I have kidney or liver problems.

I have had gastric bypass surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive preoperative medications including Celecoxib, Pregabalin, and Tramadol

1 day

1 visit (in-person)

Intraoperative

Participants receive intraoperative medications including Dexamethasone, Acetaminophen, Ropivacaine, Epinephrine, and Ketorolac

1 day

Postoperative Treatment

Participants receive postoperative medications and are monitored for pain and side effects for the first 10 days

10 days

Daily automated text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment with routine clinic visits

2 years

Visits at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-Free Pain Protocol

Trial Overview The trial tests the effectiveness of a multimodal pain control regimen without opioids against one with standard opioid medication after shoulder surgery. The main focus is on the difference in daily pain scores within the first 10 days post-operation.

How Is the Trial Designed?

Group I: Multimodal, Non-Narcotic Experimental Treatment 11 Interventions

This group will be given the preoperative, intraoperative, and discharge meds described below. This group will NOT receive any opioid-containing meds. Preoperative meds: Celecoxib: 400 mg by mouth, Pregabalin: 75 mg by mouth, Tramadol: 50 mg by mouth. Intraoperative meds: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge meds: Dexamethasone: 4 mg by mouth twice per day for 4 days (for same day discharge only), 10 mg IV on postoperative day 1 (for overnight patients only), Pregabalin: 75 mg by mouth twice per day for 14 days, Tizanidine: 2 mg by mouth every 6 hours for 14 days, Magnesium: 200 mg by mouth twice per day for 14 days, Ibuprofen: 600 mg by mouth every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg by mouth every 8 hours not to exceed 3000 mg per day for 1 month.

Group II: Multimodal Plus Narcotic Active Control 12 Interventions

This group will be given the preop, intraop, and discharge meds described below. They will also be given 35 pills of oxycodone hydrochloride 5mg to be taken every 6 hours as needed at discharge. Preoperative: Celecoxib: 400 mg PO, Pregabalin: 75 mg PO, Tramadol: 50 mg PO. Intraoperative: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge: Dexamethasone: 4 mg PO twice per day for 4 days (for same day discharge only), 10 mg IV on postop day 1 (for overnight patients only), Pregabalin: 75 mg PO twice per day for 14 days, Tizanidine: 2 mg PO every 6 hours for 14 days, Magnesium: 200 mg PO twice per day for 14 days, Ibuprofen: 600 mg PO every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg PO every 8 hours not to exceed 3000 mg per day for 1 month.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

The implementation of a Multimodal Perioperative Pain Protocol (MP3) significantly improved the quality of recovery (QoR) scores at 24 and 48 hours post-surgery in patients undergoing shoulder arthroscopy, indicating better overall recovery experiences.

Patients in the MP3 group reported enhanced pain management and reduced opioid consumption for up to three days after surgery, suggesting that this protocol effectively alleviates pain while minimizing reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. Elkassabany, NM., Wang, A., Ochroch, J., et al.[2020]

In a study of 303 patients undergoing elective abdominal colorectal surgery, approximately 67.7% were able to avoid opioid use after leaving the postanesthesia care unit, demonstrating the feasibility of an opioid-free analgesia protocol.

Patients who successfully avoided opioids tended to be older, had fewer complications, and experienced shorter hospital stays, suggesting that certain demographic and clinical factors may contribute to the success of opioid-free surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? Yap, R., Nassif, G., Hwang, G., et al.[2021]

Patients who received a multimodal analgesia regimen after shoulder arthroplasty reported lower pain scores and consumed significantly less opioids compared to those on a standard opioid-based regimen, indicating better pain management.

The multimodal approach also resulted in shorter hospital stays (1.44 days vs 1.91 days) without increasing the risk of complications or readmissions, demonstrating its safety and efficacy in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. McLaughlin, DC., Cheah, JW., Aleshi, P., et al.[2018]

Opioid-sparing and opioid-minimizing pain regimens can provide equal or better pain relief compared to traditional opioid pain medications, reducing the risk of negative side effects for patients.

The article reviews the efficacy, safety, and feasibility of implementing an opioid-sparing clinical pathway specifically for patients undergoing shoulder arthroplasty, highlighting the importance of alternative pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain Control Following Shoulder Arthroplasty: Rethinking the Need for Opioids. Turk, R., Hamid, N.[2023]

A study involving 35 patients undergoing elective shoulder arthroplasty demonstrated that an entirely opioid-free multimodal pain management protocol resulted in low pain levels (2.5 on a numeric scale) and stable pain scores postoperatively.

The opioid-free approach was safe and effective, with only 1 patient needing rescue opioids during the hospital stay, indicating a very low risk of opioid dependence or side effects associated with traditional opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. Leas, DP., Connor, PM., Schiffern, SC., et al.[2019]

A new opioid-free pain management pathway for shoulder arthroplasty significantly reduced pain levels compared to a traditional opioid-containing pathway, with lower median pain ratings at 12 hours, 24 hours, and 2 weeks post-surgery.

The opioid-free group required much less opioid medication overall (20 mg vs. 4936.25 mg in the opioid group) and reported no readmissions or significant side effects, indicating that this approach is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free shoulder arthroplasty is safe, effective, and predictable compared with a traditional perioperative opiate regimen: a randomized controlled trial of a new clinical care pathway. Jolissaint, JE., Scarola, GT., Odum, SM., et al.[2022]

Effective management of postoperative pain after shoulder surgery is crucial for improving patient outcomes and reducing reliance on narcotic medications.

The article reviews various multimodal analgesia strategies, highlighting their benefits and drawbacks, and suggests a pain management algorithm to optimize pain control during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative pain management for shoulder surgery: evolving techniques. Patel, MS., Abboud, JA., Sethi, PM.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9533185/

Effect of a Postoperative Multimodal Opioid-Sparing Protocol ... In arthroscopic knee and shoulder surgery, there is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05488847

Opioid-Free Pain Protocol After Shoulder Arthroplasty This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty.

3. 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 ...

4. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00075-5/fulltext

Multimodal, Opioid-Free Pain Management After Rotator ... The authors concluded that multimodal pain therapy after RCR provided “at least equivalent pain relief” compared to opioid analgesia. Of note, 30 (42%) of all ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/opioid-sparing-shoulder-surgery-represents-cultural-shift

Opioid-Sparing Shoulder Surgery Represents Cultural Shift Another similar study by the Cleveland Clinic team demonstrated complete elimination of opioid use by 2 weeks after shoulder arthroplasty using ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274622001288

Opioid-free shoulder arthroplasty is safe, effective, and ... Conclusion. A multimodal, opioid-free perioperative pain management pathway is safe and effective in patients undergoing total shoulder arthroplasty and offers ...