Double-blind Randomized Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo, in the Outpatients Area.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment.
研究概览
简要总结
The purpose of this study is to evaluate if applying a lidocaine topical solution before wounds treatment decreases the pain of the procedure in comparison with placebo solution.
详细描述
The manipulation of the wounds for its treatment is a painful process and there is currently no marketed any topical drug to decrease this suffering.
The objective of this study is to demonstrate that lidocaine topical solution applied prior to wounds treatment, reduces the pain of the procedure compared to the treatment done after application of placebo solution. In addition, if the process was less painful, the consumption of systemic analgesics would be reduced (or eliminated) and, therefore, also its secondary effects.
It is a single-center clinical trial, prospective, randomised, double-blind, placebo-controlled study that will include 46 patients (23 lidocaine group, 23 placebo group) who presents painful wounds during treatment in the Bellvitge University Hospital (HUB) outpatients area.
The Pharmaceutical Department of HUB prepares a dilution of lidocaine 0.5% in 20ml disposable syringes and identical disposable syringes containing 20ml saline solution (process authorized by the Spanish Agency of Medicines and Sanitary Products).
When a patient arrives at the outpatient area (dermatology or plastic surgery departments) to treat a wound, the nursery or the doctor who does the procedure evaluates the pain during the treatment. If it is 5 or more points according the "Verbal Numerical Scale" (VNS), the nursery will explain to the patient the possibility of being a participant in this study, and give the information document. If the patient is interested, the doctor of the Pain Department will be warned and an EKG and a pregnancy test (if the patient is a woman in fertile age) will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Patient who has accepted and signed the informed consent before the random process.
- •Women or men aged more than 18 years
- •Patients with painful wound treatments (> or = 5) who come to outgoing area for the treatment
- •Wounds or sores of any aetiology sauf arterial deficit that implies at minimum dermis or epidermis, it is, II to IV degree in the Spanish Classification of Sores made by the "National Group to Study and Management of Pressure Ulcers and Chronic Wounds" (GNEAUPP).
- •Women in fertile age with pregnancy test negative
排除标准
- •Precedents of allergic reaction to local anesthesics type amides.
- •Wounds or sores degree I on the GNEAUPP Classification (it is, without discontinuity of skin).
- •Wounds or sores too large (which requirej more than 40 ml of solution to cover)
- •Wounds around the eyes
- •Wounds secondary to arterial deficit
- •Patients who presents disturbance of cardiac conduction: atrioventricular block (second or third degree) or bifascicular block
- •Patients with altered level of consciousness (Glasgow Coma Scale value less than 14)
- •Patients following hemodialysis, peritoneal dialysis or continuous hemofiltration treatment
- •Patients suffering moderate or severe hepatic insufficiency
- •Pregnant or lactating women
- •Once the patient has already participate in the study during a previous wound treatment
- •Patients who refuse to participate in the study
研究组 & 干预措施
Topical lidocaine
23 patients will recieve lidocaine solution before wound treatment
干预措施: Lidocaine (Drug)
Saline serum
23 patients will recieve saline solution before wound treatment
干预措施: Saline Solution (Drug)
结局指标
主要结局
Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment.
时间窗: Maximum 10 days between the day of the recruitement and the treatment of the study.
We will register the VNS punctuation during the wound treatment the day of the recruitment and also the day of study. We expect to obtain less punctuation when lidocaine solution has been administrated vs saline solution.
次要结局
- Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain)15 minutes after wound treatment has finished.(15 minutes after each wound treatment of the study has finished.)
- Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) at 24 hours after each wound treatment of the study.(At 24 hours after each wound treatment of the study)
- Register if appears any side effect: local (alterations in the skin, pruritus...) or systemic (tinnitus, metallic flavor, arrhythmia...) during each procedure and in the next 24 hours after each wound treatment.(Up to 24 hours after each wound treatment of the study)
- Register the exact time to application of the wet gauzes with the study solution (between 7 and 15 minutes)(Between 7 and 15 minutes)
研究者
Ana Sanchez Allueva
Anesthesiologist
Hospital Universitari de Bellvitge