Bosanquet David C, Ambler Graeme K, Waldron Cherry-Ann, Thomas-Jones Emma, Brookes-Howell Lucy, Kelson Mark, Pickles Tim, Harris Debbie, Fitzsimmons Deborah, Saxena Neeraj, Twine Christopher P
Aneurin Bevan University Health Board, Royal Gwent Hospital, Cardiff Road, Newport, NP16 2UB, UK.
Division of Population Medicine, Cardiff University, 5th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK.
Trials. 2017 Dec 28;18(1):629. doi: 10.1186/s13063-017-2357-x.
Pain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes.
METHODS/DESIGN: Fifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients' perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5-10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353).
PLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study.
ISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016.
因外周动脉疾病（PAD）行下肢大截肢术后疼痛是一个重大问题。可在截肢时将外周神经导管（PNC）置于主要神经附近，并在术后持续输注局部麻醉药以减轻疼痛。尽管低质量的观察性数据表明使用PNC可减少术后阿片类药物的需求量，但关于其对疼痛影响的数据有限。“放置”（PLACEMENT）研究的目的是探讨开展一项有效性试验的可行性，以评估截肢时插入的带有持续局部麻醉药输注的PNC对术后短期和中期结局的影响。
方法/设计：将从两个中心招募50例因PAD行下肢大截肢（膝下或膝上）的患者。患者将按1:1的比例随机分组，接受标准术后镇痛，其中一组在术后前5天插入或不插入PNC并输注局部麻醉药。将收集前5天的结局数据，包括疼痛评分（主要结局，每天记录三次）阿片类药物使用情况、恶心或呕吐、瘙痒、头晕和并发症。术后2个月和6个月将联系患者，评估生活质量、幻肢痛、慢性残端痛和总医疗费用。将对至少10例患者（取决于初步编码时分析主题的饱和度）进行半结构化访谈，这些患者是经过有目的抽样的，以实现不同部位和研究组别的多样性。访谈将探讨患者对截肢后疼痛及其治疗的看法以及研究过程的体验。将对5 - 10名卫生专业人员进行半结构化访谈，以探讨该研究的可行性、保真度和可接受性。该预试验的数据将用于评估开展有效性试验的可行性，并估计计算样本量所需的参数。已获得全面伦理批准（威尔士研究伦理委员会3，参考编号16/WA/0353）。
“放置”（PLACEMENT）研究将是第一项探讨对截肢患者使用PNC治疗术后疼痛开展有效性试验可行性的研究，并为计算该研究的合适样本量提供参数。
ISRCTN.com，ISRCTN85710690。于2016年10月21日注册。欧洲临床试验数据库（EudraCT），2016 - 003544 - 37。于2016年8月24日注册。
