Safety and Efficacy of Ultrasound Guided Paravertebral Dexmedetomidine for Postoperative Pain Relief in Video Assisted Thoracoscopy Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post-thoracotomy pain
研究概览
简要总结
Postoperative pain is the most undesired consequence of surgery, and if not managed adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to reveal that postoperative pain is insufficiently managed throughout the first world, let alone in the Third World. An American survey over 20 years showed that only one in four patients had adequate relief of postoperative pain. This has led recovery room protocols to include pain as a fifth vital sign that needs to be addressed before patients are discharged to the ward
详细描述
This prospective, randomized, double-blinded, parallel assignment clinical trial will be done after receiving approval from the local ethics committee of the Faculty of Medicine, Assiut University. A written informed consent will be taken after discussing a detailed description of the study with the patients.
Patients will be allocated randomly into two equal groups by computer programs and will be contained in sealed opaque envelopes.
Patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation. Patients will be monitored with ECG, non-invasive blood pressure, heart rate, temperature, oxygen saturation, exhaled CO2 (end tidal capnography), and train of four. In both groups, general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation will be facilitated with cisatracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). Fentanyl (0.5mcg/kg) will be repeated if heart rate (HR) and/or mean arterial pressure (MAP) rise 20 % above baseline values. After the end of anesthesia induction and before surgical procedure Technique of ultrasound guided paravertebral block will be done in both groups.
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
- Double (Participant, 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
- •ASA I, II and III.
- •In the age ranged between 18 up to 60 years.
- •Elective video-assisted thoracoscopy
排除标准
- •ASA IV and V
- •Liver impairment
- •Renal impairment
- •allergy to the drugs used
- •Known contraindication for regional techniques such as:
- •Infection near the site of the needle insertion
- •Coagulopathy
- •Anti-coagulation therapy,
研究组 & 干预措施
Group A
Ultrasound guided paravertebral block with bupivacaine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) via paravertebral route.
干预措施: Bupivacaine (Drug)
Group B
Ultrasound guided paravertebral block with bupivacaine and dexmedetomidine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg) via paravertebral route (Bupivacaine plus Dexmedetomidine)
干预措施: Bupivacaine (Drug)
Group B
Ultrasound guided paravertebral block with bupivacaine and dexmedetomidine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg) via paravertebral route (Bupivacaine plus Dexmedetomidine)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
post-thoracotomy pain
时间窗: within first 24 hours after Video Assisted Thoracoscopy Surgery
5. Pain scores at rest and on coughing will be recorded using visual analogue scale (VAS) pain intensities at rest and during coughing/movement assessed by VAS score. The quality of effective analgesia will be expressed as VAS values derived from the VAS pain score, at rest and during coughing during each assessment period (2 h, at 4, 8 and 24 h).
次要结局
- rescue analgesia(within first 24 hours after Video Assisted Thoracoscopy Surgery)
- nausea, vomiting(within first 24 hours after Video Assisted Thoracoscopy Surgery)
- sedation score(within first 24 hours after Video Assisted Thoracoscopy Surgery)
- pulmonary function tests(within first 24 hours after Video Assisted Thoracoscopy Surgery)
研究者
Sayed Kaoud Abd-Elshafy
Associate profossor of anesthesia
Assiut University