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临床试验/NCT04962152
NCT04962152招募中4 期

To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月7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
60
试验地点
1
主要终点
postoperative analgesic effect

研究概览

简要总结

To evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery

详细描述

Video-assisted thoracoscopic surgery (VATS) can be associated with stronger postoperative pain than is commonly believed. Pain control after thoracic surgery is important because increased acute pain has been shown to increase the incidence of chronic pain, and untreated pain may lead to increased morbidity. It is generally accepted to introduce multimodal analgesic strategies based on regional blockade, opioids and non-steroidal anti-inflammatory drugs.

Paravertebral block (PVB) involves the injection of local anesthetic into a wedge-shaped space lateral to the spinal nerves as they emerge from intervertebral foramina. It produces ipsilateral somatosensory and sympathetic nerve blockade effective for anesthesia as well as for management of pain of unilateral origin from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is the most common technique used for patients undergoing VATS. TPVB may be useful after VATS because a single injection of local anesthesia may provide effective analgesia for the intense short-duration pain that patients experience.

Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine developed for meeting the unmet medical need of long-acting analgesics. It is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief.

The purpose of this study is to determine the safety and efficacy of TPVB combined with a single dose of intramuscular Naldebain® administered preoperatively to patients scheduled to undergo VATS.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject's age: 20~65 years old
  • American Society of Anesthesiologists (ASA) Physical Status classification: I~III
  • Patients who need postoperative pain relief due to thoracoscopic surgery

排除标准

  • The patient suffers from a communication disorder
  • The patient has coagulopathy
  • Sick with obvious heart, lung, liver or kidney disease
  • The patient's body mass index is less than 18.5 or greater than 35
  • Pregnant patients
  • Patients who took opioids for more than three weeks before surgery
  • Patients with contraindications to local anesthesia
  • Patients with a history of chronic pain
  • Patients with a history of drug allergy to Naldebain

研究组 & 干预措施

Group Naldebain

Experimental

ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately

干预措施: Nalbuphine Sebacate or Sesame oil (placebo) (Drug)

Group Placebo

Placebo Comparator

ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately

干预措施: Nalbuphine Sebacate or Sesame oil (placebo) (Drug)

结局指标

主要结局

postoperative analgesic effect

时间窗: the pain intensity was evaluated at 72 hours after surgery.

Use the visual analogue scale (VAS) score to assess the degree of pain after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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