A prospective study comparing hyperbaric Bupivacaine and hyperbaric Ropivacaine in patients undergoing elective vaginal hysterectomy under subarachnoid blockade.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the block characteristics among two groups (sensory, motor and duration of analgesia
研究概览
简要总结
Spinal anesthesia is a very old and popular technique. It is a safe and effective form of regional anesthesia that can be used as an alternative to general anesthesia in surgery. Vaginal hysterectomy is one such lower abdominal surgery which commonly involves the use of spinal anesthesia. Thus, in order to further improve and understand the safety issues as well as clinical use of spinal anesthesia in vaginal hysterectomies, new local anesthetics are being investigated for different applications.
Ropivacaine is relatively new aminoamide local anesthetic agent similar in chemical structure to Bupivacaine and has been little studied in that application. Early evaluation of the drug included few studies which stated cardiotoxicity and CNS toxicity of Ropivacaine is less as compared to Bupivacaine. But the potency of Ropivacaine is less than Bupivacaine therefore its duration and intensity will also be proportionately less as experimented in lower limb surgeries.
Considering that relatively few studies have been conducted to compare the potency and toxicity of hyperbaric Ropivacaine with hyperbaric Bupivacaine in lower abdominal surgeries, we planned to conduct a study comprising Ropivacaine 0.75% hyperbaric with Bupivacaine 0.5% hyperbaric in patients undergoing vaginal hysterectomy under subarachnoid blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA 1 & 2 BMI (18-29.9) UNDERGOING ELECTIVE VAGINAL HYSTERECTOMY WITH AN ANTICIPATED DURATION OF 120 MINUTES.
排除标准
- •REFUSAL TO PARTICIPATE IN STUDY ALLERGY TO STUDY DRUG OBESITY (BMI>30) HEIGHT <150CM OR >180CM PATIENTS IN WHICH SPACE OTHER THAN L3-L4 WAS USED FOR SUBARACHNOID BLOCK PATIENTS WITH ABSOLUTE CONTRAINDICATIONS TO SPINAL ANAESTHESIA.
结局指标
主要结局
To compare the block characteristics among two groups (sensory, motor and duration of analgesia
时间窗: Time of injection of spinal drug(0 min) | Time of onset of sensory block(T12) | Time to achieve peak sensory block | Peak sensory level | Max sensory level after 20 min | Two segment regression time | Duration of sensory block | Total duration of analgesia | Onset of motor block (MBS 1) | Time to achieve complete motor block (MBS 3) | Max bromage score achieved | Duration of motor block | Hemodynamic variables at 5 min interval initially and then 15 min interval til the end of surgery
To study hemodynamic parameters among two groups(PR, SBP, DBP, MAP)
时间窗: Time of injection of spinal drug(0 min) | Time of onset of sensory block(T12) | Time to achieve peak sensory block | Peak sensory level | Max sensory level after 20 min | Two segment regression time | Duration of sensory block | Total duration of analgesia | Onset of motor block (MBS 1) | Time to achieve complete motor block (MBS 3) | Max bromage score achieved | Duration of motor block | Hemodynamic variables at 5 min interval initially and then 15 min interval til the end of surgery
次要结局
- Any adverse events (hypotension, bradycardia, nausea and vomiting)(Total duration of surgery)