A Study comparing Dexamethasone and Dexmedetomidine as adjuvants with Bupivacaine and Lignocaine and Adrenaline in Ultrasound guided Supraclavicular Brachial plexus block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- 1. To compare the onset time of sensory and motor blockade.
研究概览
简要总结
This study aims to compare the efficacy and safety of Dexamethasone versus Dexmedetomidine when used as adjuvants with Bupivacaine, Lignocaine, and Adrenaline in ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries. A randomized controlled trial design will be followed with 98 adult patients divided into two groups of 49 each. Group 1 will receive Dexamethasone, and Group 2 will receive Dexmedetomidine as adjuvants. The primary outcomes include onset and duration of sensory and motor block, and incidence of adverse drug reactions. Secondary outcomes include hemodynamic effects and pharmacological interactions. Patients will be monitored for complications such as bradycardia, hypotension, and nerve injury. Data will be analyzed using standard statistical methods to determine which adjuvant provides superior block characteristics and safety profile. This research will help optimize postoperative analgesia and enhance patient recovery.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 to 65 years undergoing elective upper limb surgeries under Ultrasound guided supraclavicular brachial plexus block.
- •Patients classified as American Society of Anesthesiologists physical status I or II.
- •Patients willing to undergo Ultrasound-guided supraclavicular brachial plexus block.
- •Patients who provide written informed consent for participation in the study.
- •Patients with normal coagulation profile PT,APTT ,no bleeding diasthesis, platelet count more than 1 lakh and no contraindication to regional anesthesia.
排除标准
- •Patients with known allergy or hypersensitivity to local anesthetics,Adrenaline, Dexamethasone, or Dexmedetomidine.
- •Patients with coagulopathy or on anticoagulant therapy.
- •Patients with infection at the site of block or local skin infections Abscess, Hematoma, Folliculitis, Impetigo etc
- •Patients with pre-existing neurological deficits in the upper limb to be operated.
- •Patients with cardiopulmonary disease e.g., uncontrolled hypertension, ischemic heart disease, heart failure, COPD.
- •Pregnant or lactating women.
- •BMI more than 40 kg per m² morbid obesity making ultrasound-guided block difficult.
结局指标
主要结局
1. To compare the onset time of sensory and motor blockade.
时间窗: 0 hour | 15min | 30min | 45min | 60min | 90min | 120min | 3hour | 4 hour | 5 hour | 6 hour | 7 hour | 8 hour | 9 hour | 10 hour | 11 hour | TILL VAS MORE THAN OR EQUALTO 4
2. To compare the duration of sensory and motor blockade.
时间窗: 0 hour | 15min | 30min | 45min | 60min | 90min | 120min | 3hour | 4 hour | 5 hour | 6 hour | 7 hour | 8 hour | 9 hour | 10 hour | 11 hour | TILL VAS MORE THAN OR EQUALTO 4
3. To evaluate the incidence and type of adverse drug reactions associated with each adjuvant.
时间窗: 0 hour | 15min | 30min | 45min | 60min | 90min | 120min | 3hour | 4 hour | 5 hour | 6 hour | 7 hour | 8 hour | 9 hour | 10 hour | 11 hour | TILL VAS MORE THAN OR EQUALTO 4
次要结局
- 1.To compare the pharmacological interactions between local anesthetics and Dexmedetomidine and Dexamethasone in producing neuronal blockade.(2.To assess the hemodynamic effects as indicators of systemic pharmacological effects of Dexamethasone and Dexmedetomidine)
研究者
Dr KOUSIKA K
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE-560001