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临床试验/NCT05984264
NCT05984264招募中4 期

Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Assiut University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
118
试验地点
1
主要终点
The severity of pain will be assessed using the visual analogue scale (VAS).

研究概览

简要总结

The research aims to compare the efficacy of topical Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) and the standardized local lidocaine infiltration in pain management before pleurocentesis.

详细描述

Acute pain management is a core ethical concept in medical practice. During pleurocentesis, the standardized pain management is with 1% lidocaine with a 25 gauge needle for skin and a smaller gauge needle for deeper tissue. As the anesthetic injection is painful in and of itself, during these two procedures, pain management can sometimes fall short due to a lack of education and incorrect personal opinions. One example is "one needle insertion can cause less pain than two-needle insertions". Therefore, it is essential to find an alternative method that is painless and reduces procedural pain, which does not require expertise to administer. This is particularly important in centers with a high volume of patients and a lack of expert medical staff.

Another option for administering a local anesthesia is using a topical anesthetic. Generally, these are easily applied, tolerated better by patients, and have minimal systemic absorption resulting in fewer side effects6. A topical anesthetic can be a substitute for infiltrative lidocaine (IL) if it can be effective in reducing pain. Lidocaine-prilocaine cream (LPC) is an example of a topical anesthetic, which was introduced in 1980 for dermabrasion and minor surgery.

Previous research findings had noted the efficacy of LPC compared to IL in trans-radial catheterization, perineal tears following vaginal delivery, and some pediatric procedures like lumbar punctures and venipunctures. Additionally, LPC can be substituted for infiltrative prilocaine in pediatric femoral catheterization.

Hanieh Halili et al, found a significant difference between the LPC and IL groups in terms of patient pain or satisfaction levels, but their study was on a small sample size and they recommended further studies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients will be prepared for pleurocentesis.

排除标准

  • Patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
  • Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide).

研究组 & 干预措施

Pridocaine cream

Experimental

Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) will be applied at least 30 min before the pleurocentesis on the skin overlying the chosen aspiration site using ultrasound under occlusive dressing over a 5 × 5 cm area.

干预措施: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis. (Drug)

Standardized local lidocaine infiltration

Active Comparator

Anesthetize the skin over the insertion site with 1% lidocaine using the 5 ml syringe with a 25 or 27-gauge needle. Next, anesthetize the superior surface of the rib and the pleura. The needle is inserted over the top of the rib (superior margin) to avoid the intercostal nerves and blood vessels that run on the underside of the rib (the intercostal nerve and the blood supply are located near the inferior margin). As the needle is inserted, aspirate back on the syringe to check for pleural fluid. Once fluid returns, note the depth of the needle and mark it with a hemostat. This gives an approximate depth for the insertion of the thoracentesis needle. Remove the anesthetizing needle.

干预措施: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis. (Drug)

结局指标

主要结局

The severity of pain will be assessed using the visual analogue scale (VAS).

时间窗: one day

The severity of pain will be assessed using the visual analogue scale (VAS). The VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safaa Abd El-gayed Eid

Fellow

Assiut University

研究点 (1)

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