Do Uyen, Pook Makena, Najafi Tahereh, Rajabiyazdi Fateme, El-Kefraoui Charbel, Balvardi Saba, Barone Natasha, Elhaj Hiba, Nguyen-Powanda Philip, Lee Lawrence, Baldini Gabriele, Feldman Liane S, Fiore Julio F
Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, Montreal, QC, Canada.
Division of Experimental Surgery, McGill University, Montreal, QC, Canada.
Surg Endosc. 2023 Mar;37(3):2269-2280. doi: 10.1007/s00464-022-09472-8. Epub 2022 Aug 2.
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.
非阿片类镇痛（OFA）可能减轻门诊普通外科手术后与阿片类药物相关的危害；然而，应在严格的随机对照试验（RCT）中评估这种方法的相对有效性。开展关于OFA的RCT引发了重要的实际问题，包括外科医生和患者对不使用阿片类药物进行疼痛管理的犹豫。我们进行了一项定性研究，以探讨患者和临床医生对一项针对门诊普通外科手术后OFA的试点试验的看法和体验。
接受门诊腹部和乳房手术的患者被随机分配接受出院后阿片类镇痛（OA）或OFA。对参与试验的患者和临床医生进行了半结构化访谈，以了解他们的个人观点和体验。采用目的抽样以实现最大程度的多样性，招募具有不同特征的参与者。使用归纳主题分析法对转录的访谈进行评估。
对10名患者（5例腹部手术、5例乳房手术）和10名临床医生（6名外科医生、2名麻醉医生、2名护士）进行了访谈。出现了五个主要主题：参与试验的准备情况、对干预措施的术前想法、术后疼痛体验、干预措施的可接受性以及试验的完善。大多数患者对OFA持开放态度。临床医生表示愿意开具OFA处方，尤其是在侵入性较小的手术后以及使用外周神经阻滞（PNB）时。人们对疼痛控制的充分性和非阿片类药物的副作用（如非甾体抗炎药引起的出血、肾损伤）表示担忧。总体而言，参与者对试验充满热情并认识到其相关性；临床医生称赞了研究设计和组织；患者重视电子问卷的使用。改进建议包括防止因使用PNB产生潜在偏差（即通过标准化或分层）以及减轻患者负担（即减少术后问卷）。
参与试点RCT的患者和临床医生普遍接受门诊普通外科手术后OA与OFA之间的临床平衡，并认识到需要进行方法学严谨的试验，以为循证镇痛处方提供依据。
