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