Uyen Do1,2, Makena Pook1,2, Tahereh Najafi1, Fateme Rajabiyazdi3, Charbel El-Kefraoui1,2, Saba Balvardi1,4, Natasha Barone5, Hiba Elhaj1, Philip Nguyen-Powanda1,2, Lawrence Lee1,2,4,6, Gabriele Baldini1,7, Liane S Feldman1,2,4,6, Julio F Fiore8,9,10,11,12. 1. Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, Montreal, QC, Canada. 2. Division of Experimental Surgery, McGill University, Montreal, QC, Canada. 3. Department of Systems and Computer Engineering, Carleton University, Ottawa, ON, Canada. 4. Department of Surgery, McGill University, Montreal, QC, Canada. 5. Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada. 6. Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, QC, Canada. 7. Department of Anesthesia, McGill University, Montreal, QC, Canada. 8. Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, Montreal, QC, Canada. julio.fiorejunior@mcgill.ca. 9. Division of Experimental Surgery, McGill University, Montreal, QC, Canada. julio.fiorejunior@mcgill.ca. 10. Department of Surgery, McGill University, Montreal, QC, Canada. julio.fiorejunior@mcgill.ca. 11. Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, QC, Canada. julio.fiorejunior@mcgill.ca. 12. Montreal General Hospital, 1650 Cedar Ave, R2-104, Montreal, QC, H3G 1A4, Canada. julio.fiorejunior@mcgill.ca.
Abstract
BACKGROUND: Opioid-free analgesia (OFA) may mitigate opioid-related harms after outpatient general surgery; however, the comparative effectiveness of this approach should be assessed in robust randomized controlled trials (RCTs). Undertaking an RCT on OFA raises important practical concerns, including surgeon and patient hesitation regarding pain management without opioids. We conducted a qualitative study to explore patients' and clinicians' perspectives and experiences with a pilot trial focused on OFA after outpatient general surgery. METHODS: Patients undergoing outpatient abdominal and breast procedures were randomized to receive post-discharge opioid analgesia (OA) or OFA. Semi-structured interviews with patients and clinicians involved in the trial were conducted to elicit personal perspectives and experiences. Purposive sampling for maximum variation was used to recruit participants with diverse characteristics. Transcribed interviews were assessed using inductive thematic analysis. RESULTS: Ten patients (5 abdominal, 5 breast) and 10 clinicians (6 surgeons, 2 anesthesiologists, 2 nurses) were interviewed. Five major themes emerged: readiness for trial engagement, pre-trial thoughts about the interventions, postoperative pain experiences, intervention acceptability, and trial refinement. Most patients were open to OFA. Clinicians expressed willingness to prescribe OFA, particularly after less invasive procedures and when using peripheral nerve blocks (PNBs). Concerns were raised regarding the adequacy of pain control and side effects of non-opioid drugs (e.g., NSAID-induced bleeding, kidney injury). Overall, participants were enthusiastic about the trial and recognized its relevance; clinicians praised the study design and organization; and patients valued the use of electronic questionnaires. Suggestions for improvements included preventing potential bias arising from the use of PNBs (i.e., via standardization or stratification) and reducing patient burden (i.e., decreasing postoperative questionnaires). CONCLUSION: Patients and clinicians who participated in a pilot RCT generally accept the clinical equipoise between OA versus OFA after outpatient general surgery and recognize the need for methodologically robust trials to inform evidence-based analgesia prescribing.
BACKGROUND: Opioid-free analgesia (OFA) may mitigate opioid-related harms after outpatient general surgery; however, the comparative effectiveness of this approach should be assessed in robust randomized controlled trials (RCTs). Undertaking an RCT on OFA raises important practical concerns, including surgeon and patient hesitation regarding pain management without opioids. We conducted a qualitative study to explore patients' and clinicians' perspectives and experiences with a pilot trial focused on OFA after outpatient general surgery. METHODS: Patients undergoing outpatient abdominal and breast procedures were randomized to receive post-discharge opioid analgesia (OA) or OFA. Semi-structured interviews with patients and clinicians involved in the trial were conducted to elicit personal perspectives and experiences. Purposive sampling for maximum variation was used to recruit participants with diverse characteristics. Transcribed interviews were assessed using inductive thematic analysis. RESULTS: Ten patients (5 abdominal, 5 breast) and 10 clinicians (6 surgeons, 2 anesthesiologists, 2 nurses) were interviewed. Five major themes emerged: readiness for trial engagement, pre-trial thoughts about the interventions, postoperative pain experiences, intervention acceptability, and trial refinement. Most patients were open to OFA. Clinicians expressed willingness to prescribe OFA, particularly after less invasive procedures and when using peripheral nerve blocks (PNBs). Concerns were raised regarding the adequacy of pain control and side effects of non-opioid drugs (e.g., NSAID-induced bleeding, kidney injury). Overall, participants were enthusiastic about the trial and recognized its relevance; clinicians praised the study design and organization; and patients valued the use of electronic questionnaires. Suggestions for improvements included preventing potential bias arising from the use of PNBs (i.e., via standardization or stratification) and reducing patient burden (i.e., decreasing postoperative questionnaires). CONCLUSION: Patients and clinicians who participated in a pilot RCT generally accept the clinical equipoise between OA versus OFA after outpatient general surgery and recognize the need for methodologically robust trials to inform evidence-based analgesia prescribing.
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