Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Motor block duration
研究概览
简要总结
In this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. The solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg.
The main objective of this investigation is to demonstrate that using higher concentrations of bupivacaine alone results in a significant block duration increase compared with the mixture of bupivacaine and lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A research assistant will prepare the solutions before the procedure, utilizing bupivacaine alone or mixing bupivacaine and lidocaine as appropriate. The operator, patient, and investigator assessing the block will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •Surgery of the forearm, wrist, and hand
- •Weight ≥ 80 kilograms
排除标准
- •Adults who are unable to give their consent
- •Infection in the injection site (infraclavicular region)
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., platelets ≤ 100, International Normalized Ratio ≥ 1.4)
- •Renal failure (assessed by history and physical examination and if deemed clinically necessary, by blood work, i.e., creatinine ≥ 1.2)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., transaminases ≥ 100)
- •Allergy to local anesthetics (LAs)
- •Pregnancy or breastfeeding
- •Prior surgery in the infraclavicular region
- •Chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
Bupivacaine 0.25% plus Lidocaine 1%
Infraclavicular block with Bupivacaine and Lidocaine
干预措施: Bupivacaine-Lidocaine (Drug)
Bupivacaine 0.5%
Infraclavicular block with Bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Motor block duration
时间窗: 0 - 48 hours after block
The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.
次要结局
- Sensory block duration(0 - 48 hours after block)
- Analgesic block duration(0 - 48 hours after block)
- Sensory and motor block score(0 - 60 minutes after block)
- Block onset time(0 - 60 minutes after block)
- Incidence of successful block(0 - 60 minutes after block)
- Incidence of failed block(0 - 60 minutes after block)
- Incidence of anesthetic block(60 to 120 minutes after the ending time of local anesthetic injection)
- Procedural pain(Immediately after nerve block)
- Image time(2 hours before surgery)
- Needle time(2 hours before surgery)
- Block performance time(2 hours before surgery)
- Rate of diaphragmatic paresis(From 60 minutes after block to the end of the surgery)
- Duration of surgery(3 hours after skin incision)
- Number of patients requiring general anesthesia(60 to 120 minutes after the ending time of local anesthetic injection)
- Rate of diaphragmatic paralysis(From 60 minutes after block to the end of the surgery)
- Length of PACU stay(3 hours after the end of the surgery)
- Diaphragmatic function(From arrival to the pre-anesthesia unit to the end of surgery)
- Incidence of rebound pain(24 hours after the block wears off)
- Pain score in the post-anesthesia care unit (PACU)(3 hours after the end of the surgery)
- Incidence of nerve block side effects(From skin anesthesia to 60 minutes after the nerve block)
- Postoperative complications(7 days after surgery)
研究者
Germán Armando Aguilera Ceballos
Principal Investigator
Hospital de San Carlos Dr. Benicio Arzola Medina