Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of first loading preoperative dose of paravertebral injectate
研究概览
简要总结
This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.
详细描述
Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.
Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists physical status class ||or |||.
- •Patients scheduled for elective thoracotomy.
排除标准
- •Pneumonectomy, decortication, pleural biopsy.
- •Additional chest wall resection.
- •Emergency surgery.
- •Central and peripheral neuropathies.
研究组 & 干预措施
bupivacaine saline group
This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter
干预措施: Bupivacaine saline (Drug)
Dexmedetomidine- bupivacaine group
This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter.
干预措施: dexmedetomidine bupivacaine (Drug)
结局指标
主要结局
Duration of first loading preoperative dose of paravertebral injectate
时间窗: One day
Time interval between initiation of the paravertebral block and the time to first rescue analgesia
次要结局
- Duration of surgery and anesthesia(Intraoperative period, up to 3-4 hours)
- Total doses of bupivacaine, dexmedetomidine, and morphine(48 hours postoperatively)
- Number of paravertebral to-up injections(48 hours postoperatively)
- Total intraoperative crystalloid requirements(Intraoperative period, up to 3-4 hours)
- Total intraoperative fentanyl requirements(Intraoperative period, up to 3-4 hours)
- Pain intensities at rest and during coughing as assessed by 0-10 VAS score(Over 48 hours postoperatively)
- Side effects(48 hours postoperatively)
- End tidal isoflurane(Duration of anesthesia, up to 3-4 hours)
- Total intraoperative ephedrine and atropine requirements(Intraoperative period, up to 3-4 hours)
- Recovery time(Immediate postoperative period, up to 2 hour)
研究者
Professor Mohamed Abdulatif Mohamed
Professor of Anesthesiology & Surgical Intensive Care, Faculity of Medicine
Cairo University