Comparative Study of the Effect of Continuous Caudal Epidural With General Anaesthesia Versus General Anaesthesia on Intra Operative and Post Operative Analgesic Requirements for Lumbar Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determining the total amount of fentanyl that will be consumed as intra operative analgesia
研究概览
简要总结
In this clinical study, the investigators will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia. Furthermore, the investigators will determine the analgesic requirement, rescue analgesia, hemodynamic changes and possible complications with continuous caudal epidural analgesia.
详细描述
- The clinical trial will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia and using this clinical trial to prove the good analgesic effect of continous caudal epidural and its use to decrease opioid use intra and post operative.
- This clinical trial can trace intra and post operative hemodynamic changes while using continuous caudal epidural.
- This clinical trail will record the possible complications and their incidence of continuous caudal epidural.
- Sample size justification: the expected mean intra-operative narcotic consumption among study groups is 186.5 ± 21.6 µg and 106 ± 16.4 µg.
Sample size of 30 patients per group can detect the difference between two groups with power >90% and alpha error 0.05.
- Statistical analysis: this clinical trial will be carried out using the statistical software program. Description of quantitative data as mean and standard deviation and qualitative data as number and percentage.Comparison between the two groups will be done by using the Chi-square test, independent t-test or Mann-Whitney U-test according to the distribution of data. A p-value less than 0.05 will be considered statistically significant.
- Study Procedures:
Patients will be randomly allocated into two equal groups.
Preoperative setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group: Adult patients from age of 21 years to 60 years
- •Sex: Both sexes.
- •American Society Association Classification (ASA): patients with ASA classification I, II.
- •Elective lumbar fixation surgeries.
排除标准
- •Patients refuse to give informed consent.
- •Patients younger than 21 or older than
- •History of bupivacaine allergy.
- •Emergency surgeries.
- •Patients who underwent previous spine surgeries of any cause.
- •Infection at the site of injection.
- •Coagulopathy (acquired, induced, genetic).
- •ASA Classification: ASA III, IV.
- •Severe aortic stenosis, severe mitral stenosis, hypertrophic obstructive cardiomyopathy.
- •Severe hypovolemia, Severe uncorrected anemia.
- •Increased intra-cranial pressure (i.e., brain tumor or recent head injury).
研究组 & 干预措施
Combined continuous caudal epidural and general anaesthesia
-Patients will be located in the prone position for caudal epidural block.Fluoroscopy will be utilized and a lateral view will be obtained to demonstrate the anatomic boundaries of the sacral canal. A 17- or 18-gauge Tuohy-type needle will be inserted in the midline into the caudal canal. An initial dose of 20 ml of 0.25% bupivacaine will be injected in the caudal canal in order to perform sensory block and spare motor power. Then a dose of 10 ml 0.25% bupivacaine will be injected through the epidural catheter every 1-hour intra operatively and at 0-hour and 1-hour post operative. Then the catheter will be removed 1 hour post operative.
干预措施: Combined continous caudal epidural with general anaesthesia (Other)
General anaesthesia (opioid analgesia)
-General anaesthesia will be induced with administration of extra doses of fentanyl as needed according to hemodynamic changes suggesting pain sensation
干预措施: Combined continous caudal epidural with general anaesthesia (Other)
结局指标
主要结局
Determining the total amount of fentanyl that will be consumed as intra operative analgesia
时间窗: during intraoperative period (from induction of anesthesia until recovery from general anaesthesia)
the amount of fentanyl on micrograms used intra operative for both groups
次要结局
- Determining the total amount of morphine that will be given as analgesia(the first 6 hours post operative)
- Analyzing the numeric pain scale score(the first 6 hours post operative)
- Detecting effect of continuous caudal epidural analgesia on intra operative and post operative on vital data (using heart rate)(intra operative and the first 6 hours post operative)
- Identifying the time to the first demand for rescue analgesia(any time during the first 6 hours post operative)
研究者
Esraa Abdellatif
Assistant lecturer of anesthesia, intensive care unit and pain management
Ain Shams University