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Perioperative Pain Management for Shoulder Arthritis
N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at improving the effectiveness and efficiency of shoulder replacement surgery. It looks at the use of perioperative pain management strategies and careful patient selection to reduce length of stay and improve effectiveness.
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Possible side effects may include nausea from morphine; numbness or weakness due to ropivacaine; increased heart rate from epinephrine; stomach issues or kidney problems from ketorolac.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain VAS
Secondary study objectives
ASES Shoulder Score
Analgesia Diary
Constant Score
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Local Infiltration AnesthesiaExperimental Treatment1 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 BlockadeActive Control1 Intervention
Ultrasound guided brachial plexus blocade with 10 ml of 0.5% ropivacaine using a high frequency linear array transducer.
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,853 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having shoulder replacement surgery due to rheumatoid arthritis.I am having shoulder replacement surgery due to rotator cuff issues.I have had a previous thrombotic event.I am having shoulder replacement surgery due to arthritis.I am having shoulder replacement surgery due to a recent fracture.I have obstructive sleep apnea.I am having shoulder replacement surgery due to injury aftermath.
Research Study Groups:
This trial has the following groups:- Group 1: Local Infiltration Anesthesia
- Group 2: Regional Brachial Plexus Blockade
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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