A Randomized comparative Study to Evaluate the Efficacy of Fentanyl and Magnesium Sulphate as an Adjuvant to 0.375% bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block in S.M.S Medical College Jaipur.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1. To determine and compare the difference in onset and duration of motor blockade in
研究概览
简要总结
This prospective, randomized comparative study is being conducted at S.M.S Medical College and Hospital, Jaipur to compare the effectiveness of adding magnesium sulfate to 0.375% bupivacaine and fentanyl to 0.375% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients undergoing elective upper limb surgeries distal to mid-humerus. A total of 66 patients will be enrolled and randomized into two equal groups (Fentanyl group and Magnesium sulfate group). Parameters such as onset of motor block, duration of motor block, onset of sensory block, duration of sensory block, total duration of analgesia, VAS score, intraoperative and postoperative hemodynamic changes will be recorded at predefined time intervals. The aim is to identify the more effective adjuvant fentanyl or magnesium sulfate, when combined with 0.375% bupivacaine, thereby improving patient comfort, reducing analgesic requirements, and ensuring hemodynamic stability with minimal adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who provide informed written consent.
- •2.Patients scheduled for elective upper limb surgeries distal to the mid-humerus, planned under ultrasound-guided supraclavicular brachial plexus block.
- •3.Adult patients of either sex aged more than 18 years.
- •4.Patients with American Society of Anaesthesiologists (ASA) physical status I or II.
排除标准
- •1.Patients with a known allergy to any of the study drugs (bupivacaine, fentanyl, or magnesium sulphate).
- •2.Pregnant or breastfeeding women.
- •3.Patients with liver, kidney, or heart problems.
- •4.Patients with other medical conditions such as high blood pressure, diabetes, bleeding disorders, or skin infection at the injection site.
- •5.Patients who are currently participating in another clinical study.
结局指标
主要结局
1. To determine and compare the difference in onset and duration of motor blockade in
时间窗: Onset time of motor block (minutes) measured from completion of local anesthetic injection to attainment of Modified Bromage score 3. | Duration of motor block (minutes) measured from completion of local anesthetic injection to return to Modified Bromage score 0 checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. | Onset time of sensory block (minutes) measured from completion of local anesthetic injection to loss of pin-prick sensation at target dermatome. | Duration of sensory block (minutes) measured from completion of local anesthetic injection to return of pin-prick sensation at target dermatome checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr.
both the groups.
时间窗: Onset time of motor block (minutes) measured from completion of local anesthetic injection to attainment of Modified Bromage score 3. | Duration of motor block (minutes) measured from completion of local anesthetic injection to return to Modified Bromage score 0 checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. | Onset time of sensory block (minutes) measured from completion of local anesthetic injection to loss of pin-prick sensation at target dermatome. | Duration of sensory block (minutes) measured from completion of local anesthetic injection to return of pin-prick sensation at target dermatome checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr.
2. To determine and compare the difference in onset and duration of sensory blockade in both the groups.
时间窗: Onset time of motor block (minutes) measured from completion of local anesthetic injection to attainment of Modified Bromage score 3. | Duration of motor block (minutes) measured from completion of local anesthetic injection to return to Modified Bromage score 0 checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. | Onset time of sensory block (minutes) measured from completion of local anesthetic injection to loss of pin-prick sensation at target dermatome. | Duration of sensory block (minutes) measured from completion of local anesthetic injection to return of pin-prick sensation at target dermatome checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr.
次要结局
- To determine and compare total duration of analgesia between both the groups.(Duration of analgesia (minutes) will be defined as the time between the end of local anesthetic administration and the first analgesic request.)
- To determine and compare postoperative analgesia using VAS score between both the(groups.)
- To determine hemodynamic parameters between both the groups.(Intra operatively heart rate, non-invasive blood pressure and SpO2 will be checked)
研究者
Dr Shriphal Meena
Sawai Man Singh Medical College and Hospital