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临床试验/NCT04299035
NCT04299035Unknown3 期

Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年3月5日最近更新:
适应症

试验速览

阶段
3 期
入组人数
300
试验地点
1
主要终点
Visual Analog Pain Score

研究概览

简要总结

Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.

Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.

We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.

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 (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

入选标准

  • all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.

排除标准

  • Unconscious or mentally incompetent patients or those who refuse to participate in the study.

结局指标

主要结局

Visual Analog Pain Score

时间窗: 3 days

Reported immediate postoperative VAS score, up to 3rd day

Length of stay in the PACU

时间窗: 24 hours

Length of stay in postoperative care room

Total pain med consumption in the PACU

时间窗: 3 hours

Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU

次要结局

  • Length of hospital stay(30 days)
  • Chronic pain development(6 months)

研究者

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

Dmitry Natanel MD

Dr.

Soroka University Medical Center

研究点 (1)

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