The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- morphine consumption
研究概览
简要总结
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.
详细描述
Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.
Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.
Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.
In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
triple
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years
- •American society of anesthesiology (ASA) physical status of I-III
- •scheduled for elective thoracotomy
排除标准
- •Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.
- •Pregnancy
- •History of cardiovascular and gastro-esophageal surgery
- •Preexisting pain syndrome or psychological disorders
- •Severe hepatic, cardiovascular, or renal disorders
- •Allergy to calcitonin
- •Patients who will be re-operated and who will report infections
研究组 & 干预措施
bupivacaine-fentanyl group
thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.
干预措施: Bupivacaine-fentanyl (Drug)
bupivacaine-calcitonin-fentanyl group
thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml)
干预措施: bupivacaine-calcitonin-fentanyl (Drug)
结局指标
主要结局
morphine consumption
时间窗: from the end of surgery until the end of the first postoperative day
Total morphine dose consumed in the first 24 hour after surgery
Incidence of chronic pain at 3 months after surgery
时间窗: 3 months after surgery
chronic pain at 3 months after surgery
次要结局
- morphine consumption(48 hours after surgery)
- Side effects(first postoperative day)
- numerical rating scale scores(from arrival to the post-anesthesia care unit until 48 hour after surgery.)
- numerical rating scale scores(from arrival to the post-anesthesia care unit until 48 hour after surgery.)
- Side effects(first postoperative day)
- morphine consumption(48 hours after surgery)
- incidence of chronic pain(12 months after surgery)
- Intensity of chronic pain(12 months after surgery)
研究者
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university
Tanta University