Abstract
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. 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. 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). 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.
Published Version
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