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临床试验/NCT02469610
NCT02469610已完成4 期

Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Analgesic Use

研究概览

简要总结

It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. One of the most popular methods for pain control is these procedures is the Intercostal block. The Intercostal block is usually based upon topical analgesic. In this study the investigators will try to examine the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into two groups. In the control group patients will have Intercostal block after surgery and in the study group the intercostal block will be given in the beginning of the surgical procedure. All other analgesic treatment during and post-surgery will be the same in both groups. The study will evaluate pain level in the days after the surgery, analgesic medication consumption and relevant morbidity.

详细描述

Intercostal Bupivacaine block Intercostal block is a procedure during which a local anesthetic is injected to the intercostal space. This space includes the rote of the intercostal nerve. The purpose of the procedure is to block the neuropathic pain that developed due to inflammation and irritation of the nerve and other close structures. Some add steroids to the injection because of their anti-inflammatory effect.

Bupivacaine is a local anesthetic. It belongs to a group of medicines called amide- type local anesthetics. It is a well-known medication with many years of documented use in local and regional anesthesia. Bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells. This block prevents depolarization. The lack of depolarization precludes initiation or conduction of a pain signal can occur.

Study Aims This study will try to evaluate the difference in pain control during and post thoracoscopic surgery in patients who had bupivacaine intercostal block before versus after surgery.

The study main end point is the amount of analgesic medication consumption by patients during and after thoracoscopic surgery.

Secondary end points will include subjective patient's pain evaluation, length of hospital stay and post-operative complication.

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
Single (Participant)

入排标准

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

入选标准

  • Thoracoscopic surgery candidate.
  • Over 18 years old.
  • No known allergy to Bupivacaine.
  • Patient is able to read understand and singe an inform consent.

排除标准

  • Previous thoracic operation in the same side.

结局指标

主要结局

Analgesic Use

时间窗: post operative

The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)

次要结局

  • Visual Analog Pain Scale(post operative)

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Levy Faber

Dr

Carmel Medical Center

研究点 (1)

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