Purcell Anne, Buckley Thomas, King Jennie, Moyle Wendy, Marshall Andrea P
1Menzies Health Institute, Griffith University, Nathan Campus, Building N48, Room 2.10, 170 Kessels Road, Nathan, Queensland 4111 Australia.
2School of Nursing and Midwifery, Griffith University, Nathan Campus. Building N48, Room 2.06, 170 Kessels Road, Nathan, Queensland 4111 Australia.
Pilot Feasibility Stud. 2018 Jul 7;4:123. doi: 10.1186/s40814-018-0312-6. eCollection 2018.
The physical, occupational, social and psychological impact of chronic leg ulcers (CLUs) on an individual is considerable. Wound-related pain (WRP), the most common symptom, is frequently reported as moderate to severe and mostly occurs at dressing change. WRP pain may not be alleviated by oral analgesics alone. Persistent poorly controlled leg ulcer pain can negatively impact wound healing and health-related quality of life (HRQoL).
A pilot, parallel group, non-blinded, randomised controlled trial was conducted in six procedure clinics located in a public community nursing service in New South Wales, Australia to evaluate eutectic mixture of local anaesthetics (EMLA®) on painful CLUs when used as a primary dressing. The primary objective was to assess feasibility by using pre-determined criteria: at least 80% recruitment rate, 80% retention rate and 80% adherence to the study protocol. Key eligibility criteria were that participants had a painful CLU no larger than 100 cm, a numerical rating scale (NRS) wound-related pain intensity score equal to or greater than 4, low to moderate exudate, no contraindications to EMLA® and capacity to consent. One hundred and seven patients with painful CLUs were screened for eligibility; 56% ( = 60) were eligible and consented to participate in the study. Participants were randomly assigned to the intervention ( = 30) or control ( = 30) groups. The intervention group received a measured dose of the topical anaesthetic EMLA® 5% cream daily as a primary dressing for 4 weeks followed by usual wound management for a further 8 weeks. The control group received usual wound management. Participants and investigators were not blinded to the treatment. WRP was measured at every dressing change. Wound healing and HRQoL were measured at baseline, 4 and 12 weeks.
Recruitment rate was lower than expected which likely meant patients were missed. Study retention rate was 90% ( = 54). Intervention fidelity was impacted by availability of resources and patient factors such as increased WRP.
This study identified that a larger randomised controlled trial investigating EMLA® applied as a primary dressing on painful chronic leg ulcers is feasible with modifications to the study protocol.
Australian New Zealand Clinical Trials Register: Registered 16 December, 2009.
慢性腿部溃疡（CLU）对个人的身体、职业、社交和心理影响相当大。伤口相关疼痛（WRP）是最常见的症状，经常被报告为中度至重度，且大多在换药时出现。仅口服镇痛药可能无法缓解WRP疼痛。腿部溃疡疼痛持续控制不佳会对伤口愈合和健康相关生活质量（HRQoL）产生负面影响。
在澳大利亚新南威尔士州公共社区护理服务机构的六个诊疗所进行了一项先导性、平行组、非盲、随机对照试验，以评估局部麻醉剂共熔混合物（EMLA®）作为主要敷料用于疼痛性CLU的效果。主要目的是通过使用预先确定的标准评估可行性：至少80%的招募率、80%的保留率和80%对研究方案的依从性。关键纳入标准为参与者患有不大于100平方厘米的疼痛性CLU、数字评定量表（NRS）伤口相关疼痛强度评分等于或大于4、低至中度渗出液、无EMLA®使用禁忌且有同意能力。对107例疼痛性CLU患者进行了资格筛查；56%（=60）符合条件并同意参与研究。参与者被随机分配到干预组（=30）或对照组（=30）。干预组每天接受一剂定量的5%局部麻醉剂EMLA®乳膏作为主要敷料，持续4周，随后进行另外8周的常规伤口处理。对照组接受常规伤口处理。参与者和研究者对治疗不设盲。每次换药时测量WRP。在基线、4周和12周时测量伤口愈合情况和HRQoL。
招募率低于预期，这可能意味着有患者被遗漏。研究保留率为90%（=54）。干预的保真度受到资源可用性和患者因素（如WRP增加）的影响。
本研究表明，对研究方案进行修改后，开展一项更大规模的随机对照试验来研究将EMLA®作为主要敷料用于疼痛性慢性腿部溃疡是可行的。
澳大利亚新西兰临床试验注册中心：2009年12月16日注册。
