Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of bupivacaine
研究概览
简要总结
The investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone.
The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).
Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classification 1-2
- •Real weight between 80 and 100 kg
- •Body mass index between 20 and 30
排除标准
- •Adults who are not capable of giving their own consent
- •Medical history or physical findings of pre-existing neuropathy
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs)
- •Pregnancy
- •Previous surgery in the axillary region of the surgical side
研究组 & 干预措施
Perineural Bupivacaine
Bupivacaine without Dexamethasone in axillary brachial plexus blockade
干预措施: Bupivacaine Hydrochloride (Drug)
Perineural Bupivacaine plus Dexamethasone
Bupivacaine with Dexamethasone in axillary brachial plexus blockade
干预措施: Bupivacaine Hydrochloride with Dexamethasone (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of bupivacaine
时间窗: 0 to 90 minutes after the ending time of local anesthetic injection
Maximum plasmatic level of bupivacaine
次要结局
- Time to obtain the maximum plasma concentration of bupivacaine (Tmax)(0 to 90 minutes after the ending time of local anesthetic injection)
- Sensory and motor block score(30 minutes after the ending time of local anesthetic injection)
- Plasmatic concentration of bupivacaine at 45 minutes(45 minutes after the ending time of local anesthetic injection)
- Plasmatic concentration of bupivacaine at 15 minutes(15 minutes after the ending time of local anesthetic injection)
- Plasmatic concentration of bupivacaine at 30 minutes(30 minutes after the ending time of local anesthetic injection)
- Area under the curve of plasma concentration versus time at 90 minutes (AUC90)(0 to 90 minutes after the ending time of local anesthetic injection)
- Intensity of pain during block procedure(During the execution of the nerve blockade)
- Block performance time(From the skin anesthesia to the end of local anesthetic injection)
- Plasmatic concentration of bupivacaine at 60 minutes(60 minutes after the ending time of local anesthetic injection)
- Plasmatic concentration of bupivacaine at 90 minutes(90 minutes after the ending time of local anesthetic injection)
- Block onset time(30 minutes after the ending time of local anesthetic injection)
- Incidence of successful block(30 minutes after the ending time of local anesthetic injection)
- Motor block duration(48 hours after the ending time of local anesthetic injection)
- Sensory block duration(48 hours after the ending time of local anesthetic injection)
- Analgesic block duration(48 hours after the ending time of local anesthetic injection)
- Persistent neurologic deficit(7 days after surgery)
- Incidence of nerve block side effects(From the skin anesthesia to the end of local anesthetic injection)
研究者
Daniela Bravo Advis
Assistant Professor
University of Chile