A Double Blind Randomized Controlled Study For Evaluating The Role Of Dexmedetomidine as Adjuvant To 0.5% Ropivacaine In Axillary Plexus Block for Patients Undergoing Forearm And Hand Surgery.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the mean duration of analgesia between two groups.
研究概览
简要总结
**1. Proposed research details:**a) Name of candidate: Dr. Bijit Bhakta, Post Graduate Trainee, Department of Anaesthesiology, College of Medicine &Sagore Dutta, Kolkata.
b) Place of proposed research work: Orthopedics OT at OT complex, College of Medicine & Sagore Dutta, Kolkata.
c) Broad area: Anaesthesiology
d) Specific area: Analgesic duration and haemodynamics in upper limb surgery
**2. Proposed supervisor:**Dr. Anjan Das, Associate Professor, Department of Anaesthesiology, College of Medicine & Sagore Dutta, Kolkata.
3. Proposed topic of the research:ADOUBLE BLIND RANDOMIZED CONTROLLED STUDY FOR EVALUATING THE ROLE OF DEXMEDETOMIDINE AS ADJUVANT TO 0.5% ROPIVACAINE IN AXILLARY PLEXUS BLOCK FOR PATIENT UNDERGOING FOREARM AND HAND SURGERY**.**
4. **Objective of the proposed research:**The present study is aimed to compare the analgesic duration and haemodynamic effects after administration of axillary plexus block by 0.5% Ropivacaine with Dexmedetomidine as adjuvant vs Normal Saline as control.
5. **Background of the present study:**Different adjuvants have been used to prolong the duration of analgesia like Fentanyl, Clonidine, Dexamethasone and Morphine. In recent times Dexmedetomidine as been emerged as a promising adjuvant in different regional blocks. We will evaluate the effect of adding dexmedetomidine to 0.5% ropivacaine for axillary plexus blockade in comparison with normal saline as control.The primary endpoints will be duration of sensory block (duration of analgesia).
**6. Methodology:**A total of 84 patients (20-50 years) posted for elective forearm and hand surgery under axillary block were divided into two equal groups (Group R and RD) in a randomized, double-blind fashion. In group RD (n =42) 30 ml 0.5% ropivacaine +1 ml (100 μg) of dexmedetomidine and group R (n = 42) 30 ml 0.5% ropivacaine +1 ml normal saline were administered in axillary block. Sensory and motor block onset times and the block duration time to first analgesic use, total analgesic need, postoperative VAS (visual analog scale) score, hemodynamics and side-effects were recorded for each patient. The amount of motor block was assessed by Modified Bromage Scale.
MODIFIED BROMAGE SCALE
Grade Definition
4 Full muscle strength in relevant muscle group
3 Reduced strengths, but able to move against resistance
2 Ability to move against gravity, but not against resistance
1 Discrete movements of muscle (trembling) groups
0 Lack of movement
7. Expected Outcome: The use of dexmedetomidine as an adjuvant to 0.5% Ropivacaine should provide longer duration of analgesia than 0.5% Ropivacaine with normal saline as control. Both the drugs are haemodynamically stable but significant bradycardia is seen with dexmedetomidine. In the outcome of my proposed study, it will be determined whether there is any significant difference in prolonging the duration of analgesia and reducing postoperative pain.
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
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Grade I and II.
- •Enrolled for elective forearm and hand surgery.
排除标准
- •Any known hypersensitivity or contraindication to ropivacaine, dexmedetomidine
- •Pregnancy, lactating mothers
- •Hepatic, renal or cardiopulmonary abnormality,
- •Alcoholism, diabetes, long-term analgesic therapy
- •Bleeding diathesis, local skin site infections
- •History of significant neurological, psychiatric or neuromuscular disorders
- •Patients having any history of drug allergy or prolonged drug treatment.
结局指标
主要结局
To compare the mean duration of analgesia between two groups.
时间窗: Post operative period
次要结局
- 1. To compare the onset of sensory and motor block among the two groups.(2. To compare the haemodynamic changes among two groups.)
研究者
Bijit Bhakta
College of Medicine and Sagore Dutta Hospital
