The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- incidence of Rebound pain
研究概览
简要总结
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
详细描述
After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.
An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.
Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.
All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.
Sedation with 2 mg midazolam intravenously before block was administered.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age between 18 and 75 years old.
- •Patients are current for hand surgery under axillary plexus block.
- •Patients classified ASA physical status I, II and III
排除标准
- •- Contraindication to regional anesthesia.
- •Patient's disapproval.
- •Impaired cognition.
- •Patients whose surgery must be done under general anesthesia (complex hand surgery or association of other)
- •Allergy to paracetamol, dexamethasone or opioids
研究组 & 干预措施
Axillary Plexus Block with dexametasone
In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
干预措施: Dexamathsone 4mg/ml associated with experimental arm (Drug)
Axillary Plexus Block control
In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 2 mL of saline solution.
干预措施: Saline (Other)
结局指标
主要结局
incidence of Rebound pain
时间窗: 1 hour postoperatively to 48 hours postoperatively
The primary objective is the incidence of rebound pain, which was defined as severe pain (NRS ≥ 7) \[Numerical rate scale from 0 no pain to 10 worst pain\] at the surgical site during the first 48 hours postoperatively.
次要结局
- Pain score at rest(hour 1, hour 48 postoperative)
- Pain score at movement(hour 1, hour 48 postoperative)
- The analgesic consumption(hour 1, hour 24 postoperatively)
- Duration of motor block(hour 1 postoperatively, 12 hours after nerve block)
- Blood glucose level(after nerve block, 24 hours after surgery)
研究者
Olfa kaabachi, MD
PROFESSOR
University Tunis El Manar