Perioperative Pain Management for Shoulder Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must not be taking: Chronic narcotics

Disqualifiers: Allergy to study meds, Sleep apnea, Prior TSA, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate perioperative period

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Total shoulder arthroplasty (TSA) is a common and effective treatment for end-stage shoulder pathologies. Over the past 25 years, implant designs have evolved and the indications for joint replacement have expanded significantly to include arthritis, rotator cuff arthropathy, complex shoulder trauma and trauma sequelae. This has resulted in a worldwide increase in rates of shoulder replacement surgery. The concomitant increased treatment burden for health care systems has prompted interest in strategies to improve the effectiveness and efficiency of patient care such as streamlining intraoperative procedures, mitigating complications, and reducing length of stay by providing outpatient surgical care. Outpatient lower extremity arthroplasty is commonplace and provides helpful information that can guide the development of outpatient TSA such as careful patient selection and the use of standardized perioperative pain management protocols. In lower extremity arthroplasty, several authors have described challenges associated with nerve blockade and the advantages of high-volume local infiltration analgesia (LIA) for outpatient arthroplasty. Proponents of outpatient TSA also describe the importance of patient selection, standardized perioperative protocols and implementation of comprehensive perioperative pain management strategies that can include the use of perioperative ultrasound guided interscalene brachial plexus blockade with a "single shot" injection, ultrasound guided interscalene brachial plexus blockade with a temporary indwelling catheter (ISB), LIA near the surgical site, and multimodal postoperative analgesics.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic narcotic medication, you would not be eligible to participate.

What data supports the effectiveness of the drug regimen for perioperative pain management in shoulder arthritis?

Research shows that using a combination of different pain relief methods, known as multimodal analgesia, can reduce the need for opioids and their side effects after shoulder surgery. This approach, which includes regional anesthesia and non-opioid medications, has been effective in managing pain and improving patient satisfaction. ^{1 2 3 4 5}

Is perioperative pain management for shoulder arthritis generally safe for humans?

Research shows that using a combination of different pain management methods, including local anesthetics and non-opioid medications, can effectively control pain with fewer side effects compared to opioids. This approach is considered safe and helps reduce the risk of complications associated with opioid use. ^{1 2 3 4 6}

How is the Perioperative Pain Management treatment for shoulder arthritis different from other treatments?

The Perioperative Pain Management treatment for shoulder arthritis is unique because it involves a comprehensive, three-stage approach that includes preoperative, intraoperative, and postoperative phases. This method emphasizes early pain reduction through preoperative analgesia, local wound infiltration during surgery, and a combination of oral painkillers, continuous cryotherapy, and patient-controlled analgesia after surgery, which can help reduce opioid use and improve recovery. ^{1 2 4 6 7}

Eligibility Criteria

This trial is for individuals undergoing total shoulder arthroplasty, who have conditions like osteoarthritis, rheumatoid arthritis, rotator cuff issues or fractures. It's not specified who can't join the trial.

Inclusion Criteria

I am having shoulder replacement surgery due to rheumatoid arthritis.

I am having shoulder replacement surgery due to rotator cuff issues.

I am having shoulder replacement surgery due to arthritis.

Exclusion Criteria

Patients who are unable to read English

Patients previously on chronic narcotic medication

Patients not able/willing to follow up for the study period of 12 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total shoulder arthroplasty and receive either ultrasound guided brachial plexus blockade or high-volume local infiltration anesthesia

Immediate perioperative period

1 visit (in-person)

Postoperative Rehabilitation

Participants follow routine rehabilitation protocols including sling protection for 6 weeks and progressive exercises

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures collected up to 12 months

12 months

Multiple visits (in-person and remote)

Treatment Details

Interventions

• Epinephrine
• Ketorolac
• Morphine
• Perioperative Pain Management
• Ropivacaine

Trial Overview The study tests a pain management cocktail during shoulder replacement surgery. This mix includes saline solution, ropivacaine (a numbing drug), morphine (painkiller), epinephrine (to reduce bleeding) and ketorolac (for inflammation).

Participant Groups

Group I: Local Infiltration Anesthesia Experimental Treatment 1 Intervention

High volume local infiltration anesthesia with 100 mL of 0.9% normal saline (57ml), 0.5% ropivacaine (40 ml), 10 mg morphine (10 mg/ml), 0.1 mg of epinephrine (0.1 mg/ml), and 30 mg of ketorolac (30 mg/ml) divided equally into a 20 ml five-zone field infiltration into the suprascapular notch/posterior capsule (suprascapular and axillary nerves), coracobrachialis muscle, anterior deltoid muscle, superior pectoralis major muscle, and skin incision at the conclusion of the procedure by the treating surgeon.

Group II: Regional Brachial Plexus Blockade Active Control 1 Intervention

Ultrasound guided brachial plexus blocade with 10 ml of 0.5% ropivacaine using a high frequency linear array transducer.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Findings from Research

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]

References

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

Perioperative Management in Shoulder Arthroplasty: A Review of Current Practice. [2022]

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

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

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

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

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

Pain Management Strategies in Shoulder Arthroplasty. [2017]

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

Postoperative pain control after shoulder arthroscopy. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Progress on pain control during the perioperative period of shoulder arthroscopy]. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. [2022]