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

Optimizing pain management: a pilot randomized trial in patients undergoing arthroscopic shoulder surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14069845

Enrollment

Registered

2019-01-03

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff pathology or shoulder instability Musculoskeletal Diseases Rotator cuff syndrome

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: 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 25. Unable to communicate in English or French Previous participant exclusion criteria as of 10/01/2022 to 09/01/2025: 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 09/01/2025: 1. Recruitment and consent: Recruitment rate will be assessed as the number of eligible participants who consent to participate in the study, by month, every month. If patient recruitment is below 25% early in the process, we will develop methods to improve recruitment decreasing the barriers to recruitment. 2. Treatment allocation randomization, blinding: Problems will be summarized through internal communications. We will assess evaluator unblinding after the trial, and whether it was caused by study processes (solutions would be implemented during the pilot trial), active treatment efficacy, or adverse events. 3. Adherence: We will document challenges and the proposed solutions with all participating surgeons through internal communications. Adherence rate will be calculated by number of participants who adhered at least 50% of the medication as prescribed 5 days before surgery divided by the total of participants who received the prescribed medication (PMC+Block groups). If we cannot increase adherence (defined as taking at least 50% of the medication as prescribed 5 days before surgery) to occur in at least 75% of participants, we will consider the definitive trial to be non-feasible. 4. Attrition: Attrition rates will be assessed by the number of patients who consent to participate who remain in the study until the end of the follow-up period. We will assess dropout during the study. We will document challenges and the proposed solutions with all dropouts through internal communications. We consider a dropout rate of = 20% to be the threshold for a feasible future definitive RCT. 5. Response rates to questionnaires and incomplete questionnaires: We will consider 80% as an acceptable threshold. We will ask all non-responders why they did not to respond the questionnaire or the question and use this information to decide how to improve response rates. 6. Time needed to collect data. We will record how long each	—

Measure

Time frame

Current primary outcome measure as of 09/01/2025: 1. Recruitment and consent: Recruitment rate will be assessed as the number of eligible participants who consent to participate in the study, by month, every month. If patient recruitment is below 25% early in the process, we will develop methods to improve recruitment decreasing the barriers to recruitment. 2. Treatment allocation randomization, blinding: Problems will be summarized through internal communications. We will assess evaluator unblinding after the trial, and whether it was caused by study processes (solutions would be implemented during the pilot trial), active treatment efficacy, or adverse events. 3. Adherence: We will document challenges and the proposed solutions with all participating surgeons through internal communications. Adherence rate will be calculated by number of participants who adhered at least 50% of the medication as prescribed 5 days before surgery divided by the total of participants who received the prescribed medication (PMC+Block groups). If we cannot increase adherence (defined as taking at least 50% of the medication as prescribed 5 days before surgery) to occur in at least 75% of participants, we will consider the definitive trial to be non-feasible. 4. Attrition: Attrition rates will be assessed by the number of patients who consent to participate who remain in the study until the end of the follow-up period. We will assess dropout during the study. We will document challenges and the proposed solutions with all dropouts through internal communications. We consider a dropout rate of = 20% to be the threshold for a feasible future definitive RCT. 5. Response rates to questionnaires and incomplete questionnaires: We will consider 80% as an acceptable threshold. We will ask all non-responders why they did not to respond the questionnaire or the question and use this information to decide how to improve response rates. 6. Time needed to collect data. We will record how long each

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Secondary

Measure	Time frame
1. Cumulative consumption of opioids for pain management. The research nurse/assistant will assess if patients use opioids at 6 h, 1 day, and 1 week after surgery during their follow-ups at these time points. 2. Pain intensity at 1 day post-surgery. This is generally the primary outcome in trials assessing the effectiveness of POP management. We will measure POP intensity using the standardized, validated questionnaire recommended by the APS: “Patient Outcome questionnaire”(POQ). 3. Pain intensity. We will also assess pain intensity at 6 h, 1 week, 2 and 6 months post-surgery using the POQ as above. 4. Supplemental pain management. We will assess if patients received non-opioid supplemental pain management (rescue medication, other treatments) during follow-ups at 6 h, 1 day, 1 week, and 2 and 6 months after surgery, and identify the treatments received. The research nurse/assistant will be responsible for this. 5. Physical Activity. We will use the validated self-assessment portion of the POQ. This questionnaire will be used at 2 and 6 months post-surgery. 6. Frequency of adverse and serious adverse events: Adverse and serious adverse events will be recorded by the research nurse/assistant at 6h, 1 day, and 7 days post-surgery. In addition, the research nurse/assistant will contact the study surgeons weekly to assess any occurrence of serious adverse events. 7. Cost data. We will record the cost of the anesthesiologist’s time, miscellaneous items (e.g., syringes, gauze pads), and medications by region (Ontario and Quebec).	—

Measure

Time frame

1. Cumulative consumption of opioids for pain management. The research nurse/assistant will assess if patients use opioids at 6 h, 1 day, and 1 week after surgery during their follow-ups at these time points. 2. Pain intensity at 1 day post-surgery. This is generally the primary outcome in trials assessing the effectiveness of POP management. We will measure POP intensity using the standardized, validated questionnaire recommended by the APS: “Patient Outcome questionnaire”(POQ). 3. Pain intensity. We will also assess pain intensity at 6 h, 1 week, 2 and 6 months post-surgery using the POQ as above. 4. Supplemental pain management. We will assess if patients received non-opioid supplemental pain management (rescue medication, other treatments) during follow-ups at 6 h, 1 day, 1 week, and 2 and 6 months after surgery, and identify the treatments received. The research nurse/assistant will be responsible for this. 5. Physical Activity. We will use the validated self-assessment portion of the POQ. This questionnaire will be used at 2 and 6 months post-surgery. 6. Frequency of adverse and serious adverse events: Adverse and serious adverse events will be recorded by the research nurse/assistant at 6h, 1 day, and 7 days post-surgery. In addition, the research nurse/assistant will contact the study surgeons weekly to assess any occurrence of serious adverse events. 7. Cost data. We will record the cost of the anesthesiologist’s time, miscellaneous items (e.g., syringes, gauze pads), and medications by region (Ontario and Quebec).

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Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026