A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Motor block duration
研究概览
简要总结
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration. Furthermore, since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves, respectively, motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus.
详细描述
With the approval of Ethics Committee of the Hospital Clínico Universidad de Chile, a total of 50 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care in the preoperative clinic or during routine preoperative visits.
All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room.
After skin disinfection and draping, the ICB will be performed with a previously described technique. In both groups, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL. The injectate will be slowly injected through the block needle.
Patients will be randomized to receive the study drug, either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine, mixed with the above-mentioned LA solution.
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.
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 (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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •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
- •Prior surgery in the infraclavicular region
- •Chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
Perineural dexamethasone
Addition of dexamethasone 2mg to local anesthetics in infraclavicular brachial plexus block
干预措施: Dexamethasone (Drug)
Perineural dexamethasone plus dexmedetomidine
Addition of dexamethasone plus dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
干预措施: Dexmedetomidine-Dexamethasone (Drug)
结局指标
主要结局
Motor block duration
时间窗: 24-48 hours after block
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement
次要结局
- Block onset time(1 hour before surgery)
- Respiratory depression(30 minutes after the nerve block to 2 hours after surgery)
- Bradycardia(30 minutes after the nerve block to 2 hours after surgery)
- Hypotension(30 minutes after the nerve block to 2 hours after surgery)
- Sensory block duration(Time Frame: 24-48 hours after nerve block)
- Analgesic block duration(24-48 hours after nerve block)
- Block performance time(1 hour before surgery)
- Intensity of pain during block procedure(1 hour before surgery)
- Sensory and motor block score(30 minutes after the ending time of local anesthetic injection)
- Incidence of complete block(30 minutes after the ending time of local anesthetic injection)
- Incidence of nerve block side effects(0 minutes after skin disinfection to 30 minutes after the nerve block)
- Incidence of surgical anesthesia(30-60 minutes after the ending time of local anesthetic injection)
- Postoperative persistent sedation(2 hours after surgery)
- Persistent neurologic deficit(7 days after surgery)
研究者
Julian Aliste
Assistant Professor
University of Chile