Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia in Patients Undergoing Open Pulmonary Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Change in Visual Analogue Score during coughing
研究概览
简要总结
The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia. Then, A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E).Finally, the study find that Open TPVB can provided satisfactory analgesia for patients undergoing open pulmonary lobectomy under general anesthesia, and the analgesia efficacy was equivalent to the TPVB under ultrasound guidance,which should be popularized.
详细描述
Purpose: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia.
Methods: A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into 3 groups (n = 30 each) by using a random number table: PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E). In group G, patients were received PCIA after the surgery. In group U, TPVB was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml combined with the PCIA after the surgery. In group E, the TPVB was performed under the direct vision with 0.25% ropivacaine 30 ml combined with the PCIA. The Visual Analogue Score (VAS) at rest and during coughing, the sensory nerve block segment, as well as the respiratory rate were measured and recorded at different time-points. Furthermore, the hemodynamic vital signs at different time - points, the number of successfully delivered doses 48 h after the surgery, as well as the incidence of postoperative complications were also recorded and analyzed.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with American Society of Anesthesiologists physical status Ⅰor Ⅱ
- •aged 35 - 75 years old
- •with body mass index of 20 - 25 kg／m2,
- •scheduled for open pulmonary lobectomy under general anaesthesia at the First Affiliated Hospital of Kunming Medical University
排除标准
- •cardiovascular and/or cerebrovascular disease;
- •diabetes; pre-existing liver, lung or kidney dysfunction;
- •bilateral surgery; take operations again within 48 h after the surgery;
- •with serious pulmonary infection and coagulation dysfunction
研究组 & 干预措施
Placebo group (group G)
干预措施: placebo (Other)
Ultrasound-guided TPVB group (group U)
干预措施: Ultrasound-guided TPVB (Combination Product)
open TPVB group(group E)
干预措施: Open TPVB (Combination Product)
结局指标
主要结局
Change in Visual Analogue Score during coughing
时间窗: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Visual Analogue Score (VAS) during coughing was recorded 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Change in the respiratory rate
时间窗: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.
The respiratory rate was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.
Change in Visual Analogue Score at rest
时间窗: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Visual Analogue Score at rest was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
次要结局
- Change in Blood pressure(immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the)
- Change in pulse oximetry(immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the)
- The postoperative complications like agitation, respiratory depression, nausea, vomiting(up to three days after the surgery)
- The degree of parents'satisfaction with analgesia(up to three days after the surgery)
- The operating time of thoracic paravertebral block(From onset the thoracic paravertebral block to 24 hour after the surgery)
- The number of successfully delivered doses of the patient-controlled intravenous analgesia pump(48 hour after the surgery)
- Change in Heart Rate(immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the)
研究者
Wenya Bai
Resident dictor
Kunming Medical University