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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain for individuals undergoing shoulder replacement surgery due to conditions like arthritis or rotator cuff issues. It compares two main pain management methods: local infiltration anesthesia (injecting pain relief directly into the shoulder area) and regional brachial plexus blockade (using ultrasound to guide a nerve block in the shoulder area). The goal is to ease surgery recovery and potentially enable outpatient procedures, allowing patients to go home the same day. Suitable candidates for this trial include those undergoing shoulder replacement surgery for conditions like osteoarthritis or rheumatoid arthritis, excluding individuals with allergies to the study medications or certain other medical conditions. As an unphased trial, this study provides a unique opportunity to advance pain management techniques for shoulder surgery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that local infiltration anesthesia (LIA) safely and effectively manages pain during surgery. Patients receiving LIA often experience pain relief similar to those with nerve blocks but face fewer complications afterward. Research indicates that LIA reduces the need for opioids and keeps patients comfortable post-surgery.

Reports describe LIA as a reliable method for pain control without major issues. For shoulder surgeries, LIA manages pain as effectively as more complex methods like nerve blocks.

Overall, LIA is well-tolerated in surgical settings, making it a sensible choice for patients undergoing procedures like total shoulder replacement surgery. This information may ease concerns about safety and effectiveness during surgery for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these pain management techniques for shoulder arthritis surgery because they offer new ways to control pain right after the operation. The Local Infiltration Anesthesia uses a mix of medications, including ropivacaine, morphine, epinephrine, and ketorolac, delivered directly into specific areas around the shoulder. This method targets the nerves and muscles involved in shoulder movement, potentially offering more precise pain relief than traditional systemic pain medications. The Regional Brachial Plexus Blockade, on the other hand, involves an ultrasound-guided injection of ropivacaine directly into the brachial plexus, a network of nerves that controls the shoulder and arm, which can provide targeted pain relief with potentially fewer side effects. These innovative approaches aim to enhance recovery and improve patient comfort by minimizing pain and reducing the need for opioids after surgery.

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

Research has shown that local infiltration anesthesia (LIA), a treatment option in this trial, effectively manages post-surgical pain. Studies have found that LIA controls pain as well as regional nerve blocks, while also reducing opioid use and lowering complication risks. One study found that LIA reduces short-term pain after surgeries like total hip and knee replacements compared to no anesthetic use. For shoulder surgeries, LIA is gaining popularity because it targets specific areas around the joint, potentially improving pain management. Overall, these findings suggest that LIA could be a good option for managing pain in shoulder surgeries. Meanwhile, the trial will also evaluate the effectiveness of regional brachial plexus blockade, another treatment arm, in managing perioperative pain. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1045452721000997

The most effective local infiltration analgesic (LIA) in ... This prospective, randomized, double-blinded study seeks to measure the difference in efficacy between the 3 widely-used LIA cocktail formulations: Bupivacaine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7256779/

Efficacy of local infiltration anesthesia versus interscalene ... Periarticular local injection mixtures provide comparable pain control to regional nerve blocks while reducing opioid use and postoperative complications ...

3. jsesarthroplasty.org jsesarthroplasty.org/article/S1045-4527(21)00099-7/fulltext

The most effective local infiltration analgesic (LIA) in ... This prospective, randomized, double-blinded study seeks to measure the difference in efficacy between the 3 widely-used LIA cocktail formulations: Bupivacaine ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4118275/

Local anaesthetic infiltration for peri-operative pain control in ... Our results show that local anaesthetic infiltration is effective in reducing short-term pain after THR and TKR when compared with no anaesthetic infiltration.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05908851

Perioperative Pain Management for Total Shoulder ... In lower extremity arthroplasty, several authors have described challenges associated with nerve blockade and the advantages of high-volume local infiltration ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105827461830716X

Local infiltration analgesia versus interscalene nerve block ... This randomized, comparative noninferiority study showed that LIA was not less effective than ISB in controlling shoulder pain for the first 48 hours after TSA.