To Investigate the Effects of Combined Use of Naldebain® ER Injection and Precedex® After Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- poatoperative analgesic effect
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of combined use of Naldebain® ER Injection and Precedex® in patients received video-assisted thoracoscopic surgery. The main questions it aims to answer are:
- the pain intensity after surgery
- the level of dizziness after surgery Participants will receice ultrasound-guided thoracic paravertebral nerve block, intramuscular Naldebain® ER injection and intravenous Precedex® infusion.
If there is a comparison group: Researchers will compare experimental group with placebo group to see if pain and dizziness after surgery can reduced.
详细描述
Ⅰ.Protocol title: To investigate the effects of combined use of Naldebain® ER Injection and Precedex® after video-assisted thoracoscopic surgery
Ⅱ.Objectives: Video-assisted thoracoscopic surgery (VATS) is currently the mainstream of thoracic surgery, but it may also cause stronger postoperative pain than expected. Therefore, pain control after thoracoscopic surgery is very important, because increased acute pain will increase the incidence of chronic pain, and untreated pain may lead to increased postoperative complications. At present, the combined use of regional nerve block, opioids, and non-steroidal anti-inflammatory drugs is the current mainstream strategy for multimodal analgesia after thoracoscopic surgery.
Paravertebral block (PVB) involves injecting a local anesthetic into the paravertebral wedge-shaped space as it emerges from the intervertebral foramen. It produces an ipsilateral somatosensory and sympathetic block, and has good analgesic effects on anesthesia and unilaterally induced pain from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is considered the best alternative to thoracic epidural analgesia because it can provide effective immediate postoperative analgesic effect in patients undergoing VATS.
Naldebain® ER Injection is a long-acting prodrug of Nalbuphine, aimed at addressing the medical need for long-acting analgesics. It is an agonist-antagonist of synthetic phenanthrene series opioids. It is chemically related to the widely used opioid antagonist naloxone and the potent opioid pain reliever oxymorphone. At present, nalbuphine sebacate has been used in many surgical procedures to relieve postoperative pain.
Precedex® injection (dexmedetomidine hydrochloride), a centrally acting α2-receptor agonist, has the same sedative effects as other benzodiazepine drugs. However, due to the different pharmacological mechanisms, there are no side effects such as respiratory depression and delirium. In addition, according to Venn et al. in 2000, when 33 postoperative patients were using respirators in the intensive care unit, they found that the use of dexmedetomidine could reduce the use of morphine by 50%, thereby reducing the possible side effects of opioids and as a good adjuvant drug for pain relief.
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
- 18 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: 18~65 years old
- •ASA classification: I~III
排除标准
- •Patients who need postoperative pain relief due to thoracoscopic surgery
- •Exclusion Criteria:
- •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® ER Injection, COX2-inhibitor NSAIDs (such as parecoxib), or Precedex®
研究组 & 干预措施
Precedex Group
Drug: PRECEDEX INJ★ 2ML Dosage form: 100 mcg/ml dexmedetomidine Dosage: 0.1~0.4 mcg/kg/hr intravenous infusion Frequency and Duration: intrvenous infusion 12 hours after the surgery immediately
干预措施: PRECEDEX INJ★ 2ML (Drug)
Placebo Group
Drug: 0.9% Normal Sline Dosage: 0.1 ml/kg/hr intravenous infusion Frequency and Duration: intrvenous infusion 12 hours after the surgery immediately
干预措施: Normal saline (Drug)
结局指标
主要结局
poatoperative analgesic effect
时间窗: the third day after surgery, the fourth day after surgery, the fifth day after surgery, and the sixth day after surgery
Use the numerical rating scale (NRS) score to ass the intensity of pain after surgery
次要结局
未报告次要终点
