Opioid-Free Pain Protocol for Shoulder Surgery
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.12345
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.12345
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.12367
Is the opioid-free pain protocol safe for shoulder surgery?
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.12356
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.12356
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants receive preoperative medications including Celecoxib, Pregabalin, and Tramadol
Intraoperative
Participants receive intraoperative medications including Dexamethasone, Acetaminophen, Ropivacaine, Epinephrine, and Ketorolac
Postoperative Treatment
Participants receive postoperative medications and are monitored for pain and side effects for the first 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment with routine clinic visits
Treatment Details
Interventions
- Opioid-Free Pain Protocol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor