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

80 Participants Needed

Trial Summary

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 data supports the idea that Opioid-Free Pain Protocol for Shoulder Surgery is an effective treatment?

The available research shows that using an Opioid-Free Pain Protocol for shoulder surgery can be as effective as traditional methods that include opioids. One study found that this new approach is safe, effective, and predictable compared to the usual opioid-based methods. Another study highlighted that alternative pain management strategies can provide equal or even better pain relief with fewer negative side effects. Additionally, a study on multimodal analgesia, which is part of the opioid-free approach, showed a decrease in opioid use and related side effects after shoulder surgery. Overall, these findings suggest that the Opioid-Free Pain Protocol is a promising alternative to traditional opioid-based pain management for shoulder surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the Opioid-Free Pain Protocol treatment for shoulder surgery?

Research shows that opioid-free and opioid-sparing pain management approaches can provide effective pain relief for shoulder surgery, with fewer side effects compared to traditional opioid-based methods. Studies have found that these approaches can lead to similar or better pain control, reduced opioid consumption, and improved patient satisfaction. ^{1 2 3 4 5}

What safety data exists for opioid-free pain management in shoulder surgery?

Several studies have evaluated the safety of opioid-free and opioid-sparing pain management protocols for shoulder surgery. These studies indicate that such protocols can provide effective pain relief with fewer side effects compared to traditional opioid-based regimens. Specifically, research has shown that opioid-free pathways are safe, effective, and predictable, with reduced opioid consumption and related side effects. The studies reviewed include randomized controlled trials and prospective cohort studies, which support the feasibility and safety of these alternative pain management strategies. ^{1 2 3 6 7}

Is the opioid-free pain protocol safe for shoulder surgery?

Research shows that opioid-free pain management for shoulder surgery is generally safe and can provide effective pain relief with fewer side effects compared to traditional opioid-based methods. ^{1 2 3 6 7}

Is the Opioid-Free Pain Protocol a promising treatment for shoulder surgery?

Yes, the Opioid-Free Pain Protocol is promising for shoulder surgery. It provides effective pain relief without the risks associated with opioids, such as addiction and side effects. Studies show it can be as effective, or even better, than traditional opioid-based methods, improving patient recovery and satisfaction. ^{1 2 3 5 6}

How is the Opioid-Free Pain Protocol treatment different from other treatments for shoulder surgery?

The Opioid-Free Pain Protocol is unique because it avoids the use of opioids entirely, focusing instead on a combination of other pain management strategies to control pain after shoulder surgery. This approach aims to provide effective pain relief while minimizing the risk of opioid-related side effects and complications. ^{1 2 3 5 6}

What is the purpose of this trial?

This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.

Research Team

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative Pain Control Following Shoulder Arthroplasty: Rethinking the Need for Opioids. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative pain management for shoulder surgery: evolving techniques. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? [2021]