Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.
详细描述
The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.
- Type of Study: Prospective randomized comparative clinical study.
- Study Setting: The operating theatres of Ain Shams University Hospitals
- Study Period: One year
- Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.
- Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I or ASA II patients.
- •Age group: 21-70 years old.
- •Duration of procedure ≤ 180 minutes.
排除标准
- •Patients with known neurologic and psychiatric illness will be excluded from the study.
- •Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia
- •Spine abnormalities.
- •Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
- •Allergy to any of the drugs used in the study.
研究组 & 干预措施
Control group
Normal saline 2 ml will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
干预措施: Control Analgesic regimen (Drug)
Fentanyl group
Fentanyl 2 ml (100 μg) will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
干预措施: Fentanyl Analgesic regimen (Drug)
Dexmedetomidine group
Dexmedetomidine 1 ml (100 μg) plus 1 ml normal saline will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
干预措施: Dexmedetomidine Analgesic regimen (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 24 hours
time from starting epidural infusion to the time of the first request for additional pain medication
Onset of sensory analgesia
时间窗: 24 hours
will be assessed by pin prick and cold application from the start of epidural infusion till scoring 1 at the 3 point scale. Assessment will be done every 5 minutes until the onset of sensory block using a 3-point scale: 0=normal sensation, 1=loss of sensation of pin prick (analgesia), and 2=loss of sensation of touch (anesthesia).
次要结局
- Post operative Mean arterial Blood pressure(24 hours)
- Anticipated adverse events(24 hours)
- Postoperative pain score(24 hours)
- Post operative Peripheral oxygen saturation(24 hours)
- Analgesic consumption(24 hours)
- The motor block(24 hours)
- Post operative Heart rate(24 hours)