Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute and chronic postoperative pain
研究概览
简要总结
Chronic post-thoracotomy pain（CPTP）will not only have a negative impact on patients' physiology and psychology, but also affect postoperative recovery.A number of researches have demonstrated that Injury to the intercostal nerve during surgery predominantly accounts for the onset of CPTP.It is closely related to postoperative local acute inflammation and neuroinflammation. Thoracic paravertebral block (TPVB)has become a new trend for post-thoracotomy pain management.Glucocorticoids,as a adjuvant, are reported to prolong the effects of local anesthetic for peripheral nerve blocks.Diprospan is a long-acting glucocorticoid. It has been widely used in clinical treatment of various pain syndromes for powerful analgesic and anti-inflammatory effects. At present, most clinical reports are limited to the acute postoperative period, and there are few studies focusing on the long-term postoperative analgesic effect of diprospan.Therefore, it is reasonable for us to hypothesise diprospan, as a longer-acting glucocorticoid, can provide more lasting analgesic effects,or even reduce the incidence of CPTP
详细描述
PARAVERTEBRAL BLOCK (PVB) involves the injection of local anesthetic (LA) into a wedge-shaped space lateral to the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory and sympathetic nerve blockade.Since its initial application in abdominal surgery, the technique has been adapted for rib fracture, flflail chest, open cholecystectomy, hepatic-biliary surgery, outpatient inguinal hernia repair, major breast cancer surgery, and open thoracotomy patient populations.Based on several recent systematic reviews and metaanalyses,TPVB and TEA are equal in analgesic effect after thoracic surgery. Moreover, TPVB is associated with fewer side effects,such as urinary retention,nausea/vomiting,pruritus and hypotension. It can also be used for patients with coagulation disorders. Kang et al. argued that TPVB can significantly improve postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery .
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
None of the participants know which group they were in,neither of the investigators and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years
- •American Society of Anesthesiologists(ASA) physical status of I-III
- •BMI: 18.5-28 kg/m2
- •Type of operation: elective thoracoscopic lobectomy
- •The patient and/or family members have signed the informed consent -
排除标准
- •Allergic to local anesthetics or glucocorticoids
- •Preoperative use of opioids
- •Severe coagulation dysfunction
- •Severe heart, lung, liver and kidney insufficiency
- •Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
- •Peptic ulcer
- •Perform astrointestinal anastomosis recently
- •Used to have a chest surgery
- •Central nervous system disease or peripheral neuropathy
- •Perioperative blood transfusion
- •Others: such as fracture, wound repair, corneal ulcer, adrenal hypercortical disease, diabetes, pregnant women -
研究组 & 干预措施
Group R
The patient is placed in lateral decubitus position with the operative side facing up, and the thoracic paravertebral nerve block will be performed under ultrasound. We select T4-5,T6-7and T8-9 intervertebral spaces for puncture.A 30-mL bolus of a solution of 0.33% ropivacaine in saline was administered under real-time ultrasound monitoring
干预措施: Ropivacaine (Drug)
Group RD
The patient is placed in lateral decubitus position with the operative side facing up, and the thoracic paravertebral nerve block will be performed under ultrasound. We select T4-5,T6-7and T8-9 intervertebral spaces for puncture.A 30-mL bolus of a solution of 0.33% ropivacaine plus 4.67mg Diprospan in saline was administered under real-time ultrasound monitoring
干预措施: Diprospan (Drug)
结局指标
主要结局
Acute and chronic postoperative pain
时间窗: 6 months after surgery
Numeric rating scale(NRS) is used to assess chronic postoperative pain
次要结局
未报告次要终点
研究者
Yibin Qin
Associate chief physician
Affiliated Hospital of Nantong University