A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Motor block duration
研究概览
简要总结
This study will compare three different doses of perineural dexmedetomidine 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). Our research hypothesis is that 1.33 mcg/kg will provide a 15%-longer duration than 1mcg/kg, which in turn will provide a 15%-longer duration than 0.67 mcg/kg. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, respectively, we will select motor block duration as the main outcome to better target the action of dexmedetomidine on the brachial plexus.
详细描述
With the approval of Ethics Committee of the McGill University Health Centre, a total of 69 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care one day before surgery
All ICBs will be supervised by 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 each group, 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 plus PN 2 mg dexamethasone. The injectate will be slowly injected through the block needle.
Patients will be randomized to receive the study drug, PN dexmedetomidine 0.67 mcg/kg or PN dexmedetomidine 1 mcg/kg, or PN dexmedetomidine 1.33 mcg/kg 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing upper limb surgery at or below the elbow
- •age between 18 and 75 years
- •American Society of Anesthesiologists classification 1-3
- •body mass index between 18 and 35 kg/m2
排除标准
- •adults who are unable to give their own consent
- •allergy or contraindication to dexmedetomidine
- •exposure to dexmedetomidine during the previous 48 hrs
- •pre-existing neuropathy (assessed by history and physical examination)
- •coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood workup i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
- •renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. creatinine. eGFR < 90)
- •hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. transaminases ≥ 100)
- •allergy to LA
- •pregnancy (as institutional policy, female patients with childbearing potential undergoing non urgent surgery are tested preoperatively for pregnancy with blood tests)
- •breast feeding
- •prior surgery in the infraclavicular region
- •chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
0.67 mcg/kg
Addition of dexmedetomidine 0.67 mcg/kg to local anesthetics in infraclavicular brachial plexus block
干预措施: dexmedetomidine (perineural) 0.67 mcg/kg (Drug)
1 mcg/kg
Addition of dexmedetomidine 1 mcg/kg to local anesthetics in infraclavicular brachial plexus block
干预措施: dexmedetomidine (perineural) 1 mcg/kg (Drug)
1.33 mcg/kg
Addition of dexmedetomidine 1.33 mcg/kg to local anesthetics in infraclavicular brachial plexus block
干预措施: dexmedetomidine (perineural) 1.33 mcg/kg (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
- Sensory block duration(24-48 hours after block)
- Analgesic block duration(24-48 hours after block)
- Block performance time(1 hour before surgery)
- Intensity of pain during block procedure(1 hour before surgery)
- Block onset time(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 surgical anesthesia(30-60 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)
- 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)
- Postoperative persistent sedation(2 hours after surgery)
- Persistent neurologic deficit(7 days after surgery)
研究者
Julián Aliste
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre