Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain change capsaicin vs. placebo patch treatment
研究概览
简要总结
In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
- •Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale [NRS] 0-10 points) during rest or during movement > 5.
排除标准
- •History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
- •Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
- •Inflamed or injured skin at the application site
- •Signs of cognitive impairment
- •Known drug or ethanol abuse
研究组 & 干预措施
capsaicin patch
干预措施: capsaicin patch (qutenza) (Drug)
placebo patch
干预措施: Placebo (Drug)
结局指标
主要结局
Pain change capsaicin vs. placebo patch treatment
时间窗: Pain intensity assessed at baseline and at 1,2,3 months follow-up
Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.
次要结局
- Changes in HADS (Hospital Anxiety and Depression Scale) score
- Changes in QST (Quantitative sensory testing)
- Changes in intraepidermal nerve fiber density
- Changes in AAS (Activities Assessment Scale) score
- Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)
- Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia
- Changes in sleep (Sleep Interference Scale) score
- Changes in PCS (Pain Catastrophizing Scale) score
研究者
Joakim Bischoff
MD
Rigshospitalet, Denmark