Perineural Dexamethasone, Dexmedetomidine or Their Combination: an Effort to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block: A Triple-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The incidence of rebound pain after the end of anesthesia
研究概览
简要总结
Dexmedetomidine, an α2 adrenoceptor agonist, and dexamethasone, a potent anti-inflammatory steroid, are commonly used, effective, and safe adjuvants to peripheral nerve block (PNB). Both have been found to delay and reduce the incidence of rebound pain (RP), prolong the duration of sensory and motor block, and enhance analgesia without causing significant respiratory depression. Few studies have explored the effectiveness of dexmedetomidine or dexamethasone as sole adjuvants to PNB for preventing or reducing RP. However, no study has directly compared the effectiveness of these two drugs in reducing RP when used as adjuvants to local anesthetic (LA) in PNB. Due to differences in their mechanism of action, their effects on RP may differ significantly. The investigators hypothesized that the combination of dexamethasone and dexmedetomidine reduces the incidence of RP when used as adjuvants to LA in PNB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 20-65 years old
- •and ASA physical status I or II and III,
- •and of either gender,
- •who provided informed, written, and valid consent,
- •were scheduled for elective orthopedic upper limb surgeries for traumatic fractures under Supraclavicular Brachial Plexus Block.
排除标准
- •Patients with coagulopathies,
- •neurological disorders,
- •hypersensitivity to any of the study drugs, or
- •a history of previous surgeries on the affected limb
- •and those who refused to sign informed consent
研究组 & 干预措施
Group A
8 mg of dexamethasone will be added to the local anesthetic.The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
干预措施: Group A (Dexamethasone) (Drug)
Group B
1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
干预措施: Group B (Dexmedetomidine) (Drug)
Group C
8 mg of dexamethasone + 1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
干预措施: Group C (Dexamethasone + Dexmedetomidine) (Drug)
结局指标
主要结局
The incidence of rebound pain after the end of anesthesia
时间窗: 24 hours
The incidence of rebound pain after the end of anaesthesia will be measured. Rebound pain refers to a transient, intense increase in pain that occurs after the resolution of a peripheral nerve block. It represents the patient's perception of a sudden change from numbness to severe pain once the block wears off - often within the first 24 hours postoperatively. The Visual Analogue Scale (VAS) will be used to measure pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
次要结局
- Onset of Rebound Pain(24 hours)
- Duration of Rebound Pain(24 hours)
- Severity of Rebound Pain(24 hours)
- Time to first analgesic request(24 hours)
- Incidence of sleep disturbances due to surgical site pain(48 hours)
- Pain score(24 hours)
- Consumption of fentanyl(48 hours)
- Patient satisfaction.(24 hours)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University