跳至主要内容
临床试验/NCT07228949
NCT07228949进行中(未招募)不适用

Real-World Analgesic Management of Complex Regional Pain Syndrome: An Observational Study in a Tertiary Care Setting

Ciusss de L'Est de l'Île de Montréal3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
3
主要终点
Frequency distribution of first-line analgesic interventions

研究概览

简要总结

This retrospective observational study aims to describe the use and analyze the effectiveness of various analgesic interventions in patients diagnosed with Complex Regional Pain Syndrome (CRPS) at the Pain Management Center of Hôpital Maisonneuve-Rosemont (HMR) between January 2020 and October 2025.

Background:

Complex Regional Pain Syndrome is a chronic pain condition characterized by severe, persistent pain accompanied by sensory, vasomotor, sudomotor, and motor/trophic changes, often following trauma or surgery. Despite established diagnostic criteria (Budapest criteria), its pathophysiology remains poorly understood, and evidence-based treatments are limited. While multidisciplinary functional rehabilitation remains the cornerstone of management, various analgesic interventions are used to facilitate recovery when medications fail to adequately control pain.

Common interventions include:

  • Plexus or peripheral nerve blocks (brachial or sciatic, with or without adjuvants such as dexamethasone or dexmedetomidine)
  • Intravenous ketamine infusions
  • Sympathetic blocks (stellate or lumbar)
  • Intravenous pamidronate infusions

Although all these techniques are used in clinical practice, their relative efficacy and predictive factors for success remain unknown. Clinicians rely on experience rather than data-driven guidance to select an initial intervention. Identifying factors such as CRPS subtype or symptom duration that predict analgesic response could improve treatment efficiency and functional recovery.

Methods:

This is a retrospective chart review including all adult patients with a CRPS diagnosis established using the Budapest criteria who received at least one eligible analgesic intervention during the study period. Data will be extracted from electronic medical records by the research team. Exclusion criteria include incomplete clinical documentation or missing information regarding the first consultation, intervention type, or analgesic outcome.

Collected variables include demographics, medications, CNESST (workers' compensation) status, PTSD diagnosis, trauma type, CRPS characteristics (affected limb, type, subtype, symptom duration), details of the first intervention (technique, dose, use of adjuvants), analgesic response, and adverse effects.

详细描述

STUDY MODEL Retrospective observational study in the form of a chart review. STUDIED POPULATION AND PERIOD Patients followed at the Maisonneuve-Rosemont Hospital Pain Management Center (PMC) for complex regional pain syndrome (CRPS) who received at least one analgesic intervention between January 1, 2020 and October 2025.

This period was chosen to obtain a sufficient number of patients and to best reflect current practice.

SAMPLE SIZE A sample size calculation will not be performed for this study. The PMC is a tertiary pain clinic that treats a large number of patients, and it is estimated that the chosen period will yield a sample of approximately 200 patients.

GENERAL PROCEDURE Data will be collected from digitized records in the Clinibase and Oacis clinical applications.

An initial sampling of charts will be performed in Clinibase by the planning, programming, and research department of the CIUSSS de l'Est-de-l'Île-de-Montréal. A search of the Clinibase database using the type of appointment at the Pain Management Center between January 1, 2020, and October 23, 2025, will provide the chart numbers of potentially eligible patients. The appointment types searched will include: block, ketamine infusion, pamidronate, stellate block, and lumbar sympathetic block.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of complexe regional pain syndrome
  • Patients who received at least one of the following intervention: peripheral nerve block (infraclavicular, intrerscalene, axillary, popliteal sciatic), sympathetic block (stellate, lumbar), intravenous ketamine infusion, or intravenous pamidronate infusion)

排除标准

  • First consultation is not digitalized
  • Information on signs and symptoms at the first consultation is missing

结局指标

主要结局

Frequency distribution of first-line analgesic interventions

时间窗: within 6 months of first visit at the Pain Clinic

To determine the frequency distribution of first-line analgesic interventions used in patients with complex regional pain syndrome

次要结局

未报告次要终点

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veronique Brulotte

Doctor

Ciusss de L'Est de l'Île de Montréal

研究点 (3)

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