A Comparative study of postoperative analgesic efficacy after infiltrating Bupivacaine with Dexmedetomidine vs Bupivacaine alone at surgical incision site in below umbilical surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- To estimate the duration of postoperative analgesia after local infiltration in both groups, Bupivacaine alone and Bupivacaine mixed with Dexmedetomidine
研究概览
简要总结
This study is a prospective, interventional, randomized comparison of the postoperative analgesic effect of bupivacaine with dexmedetomidine versus bupivacaine alone for local infiltration at the surgical incision site in infraumbilical surgeries. A total of 148 patients aged 18 to 50 years undergoing infraumbilical surgeries were randomly divided into two groups. Group DB received 20 mL of 0.25 percent bupivacaine with 50 mcg dexmedetomidine, and Group PB received 20 mL of 0.25 percent bupivacaine with 0.5 mL normal saline. The study assessed duration of analgesia, total rescue analgesic requirement in 24 hours, VAS pain scores, and hemodynamic changes. Pain was measured using the Visual Analogue Scale at regular intervals and rescue analgesia was administered if the VAS score was 4 or more. Hemodynamic parameters were monitored, and data were analyzed using standard statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients giving informed consent to participate in the study.
- •2.All patients posted for below umbilicus surgeries.
- •3.Age of the patient between 18-50 years.
- •4.Patients belonging to ASA I & ASA II.
排除标准
- •1.Patients with morbid obesity 2.Patients with Raynaud’s disease 3.Patients belonging to ASA class III and IV.
- •4.Patients with co morbidities 5.Patients with infection at the site of infiltration.
- •6.Patients with psychiatric disorders.
- •7.Patients with history of hypersensitivity to any of the drugs under study.
结局指标
主要结局
To estimate the duration of postoperative analgesia after local infiltration in both groups, Bupivacaine alone and Bupivacaine mixed with Dexmedetomidine
时间窗: at 5 minutes, 30 minutes, 45 minutes, 75 minutes, 90 minutes, 2hour, 4 hour, 6 hour, 12 hour, 24 hour
次要结局
- To calculate the total amount of rescue analgesic consumed in 24 hours(at 3 hour, 6 hour, 12 hour, 24 hour)
- To observe VAS score after infiltration(at 5 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 2 hour, 4 hour, 6 hour, 12 hour, 24 hour)
- To observe the hemodynamic changes after local infiltration of Dexmedetomidine added to Bupivacaine at incision site(at 15 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hour, 6 hour, 9 hour, 12 hour, 16 hour, 20 hour, 24 hour)