Ekkunagul Thanapon, MacLeod Caitlin Sara, Francis Jeevan, Nagy John, Forget Patrice
Epidemiology Group, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, Aberdeen, UK
Department of Vascular Surgery, Ninewells Hospital and Medical School, Dundee, Scotland, UK.
BMJ Open. 2025 Jul 16;15(7):e090678. doi: 10.1136/bmjopen-2024-090678.
Chronic limb-threatening ischaemia (CLTI) represents a severe and debilitating condition characterised by inadequate blood supply to the extremities, leading to acute and persistent pain, ulceration and a heightened risk of limb loss. Patients with CLTI often experience chronic pain that significantly impairs their quality of life. The pain experienced by patients with CLTI can be complex and challenging to manage, requiring a refined approach to balance analgesic efficacy with potential adverse pharmacological effects and pre-existing, competing comorbidities. This systematic review protocol aims to explore, critically assess and compare the effectiveness and safety of different pharmacological and locoregional analgesic approaches for managing pain occurring secondary to CLTI.
The methods will be performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Five electronic databases will be searched. At least two reviewers will perform study screening, data extraction and quality assessments. Any disagreements will be arbitrated by an additional independent reviewer. Randomised studies, observational cohort studies and case series consisting of four or more patients will be included. Grey literature will be excluded. The primary outcome will be the effectiveness of analgesia. Secondary outcomes will include adverse effects of analgesia and functional outcomes. Where the data allow, appropriate quantitative synthesis methods will be pursued.
This systematic review will not involve primary data collection; thus, no ethical approval is required. The results will be disseminated in a peer-reviewed publication and presented at conferences.
CRD42024561800.
慢性肢体威胁性缺血（CLTI）是一种严重且使人衰弱的疾病，其特征是肢体血液供应不足，导致急性和持续性疼痛、溃疡以及肢体丧失风险增加。CLTI患者常经历慢性疼痛，这严重损害了他们的生活质量。CLTI患者所经历的疼痛可能很复杂且难以处理，需要一种精细的方法来平衡镇痛效果与潜在的药物不良反应以及已有的并存疾病。本系统评价方案旨在探索、严格评估和比较不同的药物和局部区域镇痛方法在治疗CLTI继发疼痛方面的有效性和安全性。
将按照系统评价和Meta分析的首选报告项目（PRISMA）声明进行方法学操作。将检索五个电子数据库。至少两名评审员将进行研究筛选、数据提取和质量评估。任何分歧将由另一位独立评审员进行仲裁。将纳入随机研究、观察性队列研究以及包含四名或更多患者的病例系列。灰色文献将被排除。主要结局将是镇痛效果。次要结局将包括镇痛的不良反应和功能结局。在数据允许的情况下，将采用适当的定量综合方法。
本系统评价不涉及原始数据收集；因此，无需伦理批准。结果将在同行评审的出版物中发表，并在会议上展示。
PROSPERO注册号：CRD42024561800。
