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临床试验/NCT00822419
NCT00822419Unknown4 期

Percutaneous Ketamine Versus Lidocaine for Mid-Sternotomy

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
75
试验地点
1
主要终点
Reduced postoperative pain

研究概览

简要总结

Since midsternotomy is painful postoepratively, and since ketamine has been shown to be optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous preemptive effect, comparing it to lidocaine effect.

详细描述

Ketamine hydrochlorid is a general anesthetic that is also used as short term sedative. Ketamine has an antagonistic effect on the central spinal N-Methyl-D-Aspartate (NMDA) receptors, the latter modulating pain stimuli generated peripherally on their way to central pain centers.

Ketamin has been used recently pre-operatively rather than post-operatively. Our recent experience with pre-operative use of ketamine has not been analyzed yet by Tel Aviv Medical Center's researchers. There is also some experience with topical dermal, epidural, intra-articular and oral usage of ketamine.

As far as we no, there are no reports on patients' subjective feeling when ketamine was given pre-operatively for postoperative acute pain in patients undergoing mid-sternotomy for lung and cardiac surgery. The possible influence of such an effect on the patient's well-being and the patient's family feelings and reactions were neither explored.

The goal of the study is to examine the possibility that if ketamine is administered in the pre-operative period, as a topical ointment, this will induce changes in the patient's sensation of pain, his own satisfaction, and possibly his family's satisfaction as well. The basis of this contention is that by administering less morphine (which is given to the patient in the immediate post-operative period through PCA [Patent-Controlled Analgesia]), with or without changes in pain, might have positive effects on the patient's well being and his family's. This issue will be assessed by a verbal questionnaire and based and on a visual analog scale (VAS).

Three groups of 25 patients each will be enrolled in the study. The first group will receive a placebo topical paste which will be produced by the hospital pharmacy. The second group will be given lignocain paste, and the third group will get ketamine topical paste, prepared by the pharmacy as well. The study will be double blind and randomized. All patients will be treated with morphine postoperatively, as mentioned above.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients undergoing sternoromy for cardiac or chest sturgery

排除标准

  • emergency surgery

研究组 & 干预措施

lidocaine

Active Comparator

Lidocaine 5% cream 5 gr will be double blindly put on the skin preoperatively

干预措施: lidocaine (Drug)

ketamine

Experimental

ketamine cream 5% 5gr will be put on the skin preoperatively

干预措施: ketamine (Drug)

placebo

Sham Comparator

non-drug similar cream will be put on the skin preoperatively

干预措施: non-drug cream (Drug)

结局指标

主要结局

Reduced postoperative pain

时间窗: 3 months

次要结局

  • Overall satisfaction(3 months)

研究者

申办方类型
Other Gov

研究点 (1)

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