ISRCTN14069845进行中（未招募）未知
Optimizing pain management: a pilot randomized trial in patients undergoing arthroscopic shoulder surgery
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •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 (
研究者
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