Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to the 1st rescue analgesia
研究概览
简要总结
The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.
详细描述
Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.
As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-III.
- •Scheduled for open thoracotomy.
排除标准
- •Patients with neurological or intellectual disability.
- •Infection at the injection site.
- •Opioid addiction.
- •Allergic reaction to local anesthetics.
- •Coagulation abnormalities.
- •Drug abuse.
- •Pregnancy.
- •Severe liver and/or renal failure.
- •Uncontrolled hypertension.
- •Severe cardiovascular problems.
- •Diabetes mellitus.
研究组 & 干预措施
Ketamine group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
干预措施: Ketamine (Drug)
Ketamine group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
干预措施: Bupivacaine (Drug)
Dex group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
干预措施: Dexmedetomidine (Drug)
Dex group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to the 1st rescue analgesia
时间窗: 48 hours postoperative.
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
次要结局
- Intraoperative fentanyl consumption(Intraoperative)
- Total morphine consumption in the 1st 24hr and 48 hr(48 hours postoperatively.)
- Degree of pain(48 hours postoperatively.)
- Heart rate(Till the end of surgery.)
- The incidence of adverse events(48 hours postoperative)
- Mean arterial blood(Till the end of surgery.)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University