Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Duration of postoperative analgesia in hours
研究概览
简要总结
The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures.
Primary outcome: duration of postoperative analgesia. Secondary outcome: include [The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.
详细描述
Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone .
Dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres .
Tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures
- •Both sexes
排除标准
- •Patients with known allergy to the study drugs
- •Skin infection at site of needle puncture
- •Significant organ dysfunction
- •Coagulopathy
- •Drug or alcohol abuse
- •Epilepsy and psychiatric illness that would interfere with perception and assessment of pain
研究组 & 干预措施
Group (T) : 30 patients (Tramadol group)
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.
干预措施: Levobupivacaine (Drug)
Group (D) : 30 patients (Dexamethasone group):
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Duration of postoperative analgesia in hours
时间窗: 24 hours
Duration of postoperative analgesia in hours
次要结局
- The anesthesia onset time(20 minutes)
- Dose of Paracetamol as rescue analgesia in mg(24 hours)
- Presence of complications and side effects(24 hours)
研究者
Esraa Gamal
Resident of Anesthesia, ICU and Pain management
Assiut University