INCIDENCE OF REBOUND PAIN WITH OR WITHOUT DEXMEDETOMIDINE AS AN ADJUVANT IN SUPRA-CLAVICULAR BLOCK - A RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To determine whether the addition of dexmedetomidine to the local anesthetic solution used in supra-clavicular block reduces the incidence of rebound pain in patients undergoing upper limb surgeries compared to those receiving local anesthetics alone.
研究概览
简要总结
1. Introduction :
Regional anesthesia is common for upper limb and upper thorax surgeries, but the ideal local anesthetic remains uncertain. Bupivacaine and lignocaine are standard, while dexmedetomidine, an α2-receptor agonist, is being explored as an adjuvant. Our trial evaluated dexmedetomidine’s addition to bupivacaine and lignocaine for supra-clavicular brachial plexus block, aiming to reduce local anesthetic doses and rebound pain.
2. Research questions :
In patients undergoing upper limb surgeries receiving supra-clavicular block, does the addition of dexmedetomidine as an adjuvant affect the incidence and severity of rebound pain compared to supra-clavicular block without dexmedetomidine?
3. Research hypothesis-
Null Hypothesis: There is no significant difference in the occurrence of rebound pain between patients receiving supraclavicular block with dexmedetomidine and those without dexmedetomidine.
Alternative Hypothesis: There is a significant difference in the occurrence of rebound pain between patients receiving supraclavicular block with dexmedetomidine and those without dexmedetomidine
Study procedure: (briefly explained in Sequence)
- After approval of Ethical committee
- After obtained informed written consent from the patient
- Patients will be divided into two groups
- GROUP A: Patients receiving supra-clavicular block with dexmedetomidine as an adjuvant along with the local anesthetic.
- GROUP B: Patients receiving supra-clavicular block without dexmedetomidine, but with
- the same local anesthetic used in the dexmedetomidine group.
- Rescue analgesic requirement in the first 24 post-operative hours
- Visual Analogue Scale(VAS) scores at 0-10 and 24h until the first analgesic request
- Incidence of rebound pain associated with supra-clavicular nerve block with or without dexmedetomidine
- Correlation of data and comparison of post-operative analgesia provided by supra-clavicular nerve block with or without dexmedetomidine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Scheduled for elective surgeries (upper limb, upper thorax) requiring supra-clavicular block.
- •ASA physical status classification I or II.
- •Willingness to participate and provide informed consent.
排除标准
- •Contraindications to supra-clavicular block.
- •Allergy or intolerance to dexmedetomidine or local anesthetics.
- •History of chronic pain syndromes or opioid dependence.
- •Pregnant or breast feeding women.
- •Significant co-morbidities.
- •Inability to communicate effectively or understand study instructions.
结局指标
主要结局
To determine whether the addition of dexmedetomidine to the local anesthetic solution used in supra-clavicular block reduces the incidence of rebound pain in patients undergoing upper limb surgeries compared to those receiving local anesthetics alone.
时间窗: first 24 hours from the time of drug injection
次要结局
- Compare rebound pain in dexmedetomidine vs. control.(Analyse opioid use post-surgery with/without dexmedetomidine.)
研究者
Dr Prasanna Vadhanan
Vinayaka mission medical college and hospital