Optimizing pain management: a pilot randomized trial in patients undergoing arthroscopic shoulder surgery
Rotator cuff pathology or shoulder instability
Current interventions as of 04/07/2025: Consenting patients will be randomly assigned to receive one of two study interventions: Block, or PMC+Block. PMC Group: Pregabalin: 25mg at night on the 5th day prior to surgery, 25mg BID on the 4th day prior to surgery, 50 mg BID on the 3rd day prior to surgery, 75 mg BID on the 2nd and 1st day prior to surgery. In our pilot data (Section 3.5), 75 mg BID appeared effective and it is less likely to create adverse events. If patients do not tolerate the 75mg dose (e.g. sedation), we will use the greatest tolerable dose. Non-steroidal anti-inflammatory drugs: Celecoxib 100 mg PO BID starting 5 days prior to surgery. In case of contra-indication or intolerance, Naproxen EC 500 mg PO BID for 5 days will be used. Block Group: Interscalene Block. An anesthesiologist experienced in providing nerve blocks will administer a preoperative single-shot interscalene block, approximately 1 hour prior to the start of surgery. Either ropivacaine or bupivacaine in a volume of 5-15 ml, and a concentration of 0.5%, with no adjuvants, will be used. We will not use continuous interscalene block due to logistical challenges. Duration of the treatment. For the PMC and PMC+Block groupsgroup, they will receive the PMC 5 days prior to their surgery date. The duration of treatment for these groups is thus 5 days. The Block group will receive their treatment right before their surgery – the duration of treatment is therefore 1 day. Following that, all groups will receive the same, standard postoperative treatment. All participants will have their last follow-up assessment performed at 6 months post-surgery. The time points for follow-ups are at 6 hours, 24 hours, 7 days, 2 and 6 months post-surgery. Randomization. We will apply stratified randomization of patients by surgeon using random number generation by an independent third party. To improve blinding, distinct evaluators will be making assessments. A research assistant will assess POP intensit
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.
Current participant exclusion criteria as of 09/01/2025: 1. Allergies to any of the following drug combinations: 1.1. pregabalin, or 1.2. both celecoxib and naproxen EC; or 1.3. bupivacaine 2. Allergic-type to 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, or both celecoxib and naproxen EC; or 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. 24. Patients with BMI < 19 will be excluded