Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- -Post operative Visual analogue scale VAS score
研究概览
简要总结
This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.
详细描述
This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) status of I and II
- •undergoing forearm surgeries
排除标准
- •coagulopathies
- •Local skin lesions
- •Pregnancy
- •Has a history of significant neurological, psychiatric, or neuromuscular disorders
- •Patients refusing participation
- •BMI > 40
- •Patient with COPD. hypersensitivity or allergies to local anesthesia
研究组 & 干预措施
Group A (DT): Dexmedetomidine group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexmedetomidine 100 µg for the supraclavicular block.
干预措施: Group A (DT): Dexmedetomidine group (Procedure)
Group B (MG): Magnesium group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus magnesium sulfate 150 mg in 2 ml of normal saline for the same block.
干预措施: Group B (MG): Magnesium group (Procedure)
Group C (DM): Dexamethasone group
A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexamethasone 8 mg for the same block.
干预措施: Group C (DM): Dexamethasone group (Procedure)
结局指标
主要结局
-Post operative Visual analogue scale VAS score
时间窗: Over 24 hours post operative starting from transeferring the patient to the recovery area.
Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.
次要结局
- Postoperative transient neurologic symptoms(Over 48 hours post operative starting from transeferring to the recovery area.)
- Onst of sensory block(Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes)
- Onset of motor block(Complete motor block will be assessed every 5 min up to a maximum of 30 minutes)
- Duration of the sensory block(Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .)
- duration of the motor block(Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours)
- Intraoperative mean arterial blood pressure(From positioning the patient to the block upto 90 minutes from removing the needle)
- Intraoperative Pulse rate.(From positioning the patient to the block upto 90 minutes from removing the needle)
- Post operative opioid consumption(Over 24 hours post operatively started form transferring the patient to the recovery area)
- Post operative Nausea and vomiting(Over 24 hours post operative starting from transferring to the recovery area.)
研究者
Mohammed Gaber Saad
Lecturer of anesthesia, Intensive care and pain management.
Al-Azhar University