Testing the feasibility of a clinical trial comparing a pre-surgery medication cocktail and nerve-numbing injections for pain management after minimally invasive shoulder surgery

Not Applicable

• Conditions: Rotator cuff pathology or shoulder instability; Musculoskeletal Diseases; Rotator cuff syndrome

• Registration Number: ISRCTN14069845
• Lead Sponsor: Canadian Institutes of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-03
• Last Update Posted: 24 January 2022
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Aged 18 years or older
2. Understand English or French;
3. Undergoing arthroscopic surgery for shoulder rotator cuff pathology or shoulder instability with at least 6 months of symptoms.

Exclusion Criteria

Current participant exclusion criteria as of 10/01/2022:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
1. Allergies to any of the following drug combinations:
1.1. Pregabalin
1.2. Both celecoxib and naproxen EC
1.3. Both ropivacaine and bupivacaine
2. Allergic-type reactions to sulfonamides
3. History of asthma, urticaria, or allergic-type reactions after taking Acetylsalicylic Acid (ASA) or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance-rhinosinusitis, urticaria/angioedema, nasal polyps, asthma)
4. Angioedema
5. Bleeding disorders
6. History of ulcers
7. Inflammatory bowel disease
8. Cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax)
9. Ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina)
10. Congestive heart failure (NYHA II-IV)
11. Liver impairment
12. Renal impairment (Renal impairment is identified by an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2. This valued is estimated from a calculator found at https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation)
13. Known hyperkalemia
14. Chronic pulmonary lung disease (COPD)
15. Contraindications to pregabalin, both celecoxib and naproxen EC, or both ropivacaine and bupivacaine
16. Current use of high-dose opioids (>60 mg equivalents of morphine), gabapentinoids, antidepressants, antipsychotics, or cannabinoids
17. Cancer
18. Pregnancy or lactation. All females under age 55 get pregnancy tests prior to surgery. If they are pregnant, the surgery is cancelled. This procedure is not specific to this study, but a standard practice for all hospitals before surgery.
19. Frail or debilitated patients
20. Life expectancy of less than one year
21. Those without DSQ (Dossier Santé Québec) or ClinicalConnect (Ontario) access
22. Cannot be randomized to receive an interscalene block
23. Patients who refused to do a blood test.

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Previous exclusion criteria as of 12/05/2021:

1. Allergies to any of the following drug combinations:
o pregabalin, or
o both celecoxib and naproxen EC; or
o both ropivacaine and bupivacaine
2. Allergic-type reactions to sulfonamides
3. History of asthma, urticaria, or allergic-type reactions after taking Acetylsalicylic Acid (ASA) or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance-rhinosinusitis, urticaria/angioedema, nasal polyps, asthma);
4. Angioedema
5. Bleeding disorders
6. History of ulcers
7. Inflammatory bowel disease
8. Cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax)
9. Ischemic heart disease (

Study & Design

• Study Type: Interventional
• Study Design: Not specified