Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain, as Well as the Changes of the Postoperative Breathing Function Values, a Randomized, Controlled, Prospective Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 10% reduction of the thoracotomy pain recorded by VAS score.
研究概览
简要总结
The purpose of the study is to examine if the hyposthesis of the preventive analgestic characteristic of diclofenac given preoperatively has any effect on postoperative thoracic wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption and the postoperative lung function test values.
详细描述
Introduction Thoracotomies are thought to be one of the most difficult surgical incisions to deal with post-operatively, because they are extremely painful and the pain can prevent the patient from breathing effectively. Currently in our institute the surgical and post-operative anelgesia are managed by the combination of local anesthetics and opioid pain killers through an epidural cannula. In addition the investigators give diclofenac intravenously (from the 2nd day after the operation per os) as well as nalbuphin is given intravenously to the patients if it is necesserary.
By definition pre-emptive analgesia means that the treatment of pain is initiated before the surgical procedure by analgetics or nerve blockade techniques. The purpose of this method is to inhibit the production of inflammatory mediators and the prevention of the pain stimulus entering the central nervous system. As a result of the pre-emptive antinociceptive treatment, the quantity of post-operative medications can be decreased, the analgesia has less complications and the patients are more satisfied.
In the study the researchers would like to examine the pre-emptive analgetic effect of diclofenac.
Patients and methods:
Patients undergoing thoracotomy are divided into two groups.:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •100 thoracotomy patients who agreed to take part in our study and signed a consent
- •age 18-80 years
- •ASA I-III
- •men/women equally
- •thoracotomies are managed with using intratracheal double lumen tube
- •insertion of thoracic epidural cannula and during the operation administration of 1mg/ml bucain, 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed
排除标准
- •acute operation
- •diclofenac allergy in the anamnesis
- •the lack of thoracic epidural cannula
研究组 & 干预措施
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Diclofenac (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Midazolam (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Atropine (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: bucain + fentanyl (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Nalbuphine (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Metamizole-sodium (Drug)
Diclofenac group
Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Tramadol (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Midazolam (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Atropine (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: bucain + fentanyl (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Nalbuphine (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Diclofenac (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Metamizole-sodium (Drug)
Control group
Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.
Every patient recieved additional thoracic epidural analgesia during and after the surgery.
As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
干预措施: Tramadol (Drug)
结局指标
主要结局
10% reduction of the thoracotomy pain recorded by VAS score.
时间窗: 5 days
Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group.
次要结局
- 10% reduction of the shoulder pain recorded by VAS score.(5 days)
研究者
Tamas Vegh, MD
MD, PhD assistant professor anesthesiologist and intensive care specialist
University of Debrecen