Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 主要终点
- Postoperative pain
研究概览
简要总结
Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric patients has not been investigated. This study was designed to determine the effect of perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients
详细描述
150 children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine guided by ultrasound visualisation were randomly assigned to one of the five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). The primary endpoint was the minimum local anesthetic concentration (MLAC), which was determined using the Dixon up-and-down method. The secondary endpoints were the duration of analgesia and sedation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I,II children, aged between 2 and 6 years, who were scheduled for arm and forearm surgery underwent supraclavicular brachial plexus blocks.
排除标准
- •any subjects with neurological, neuromuscular, psychiatric, or blood clotting disorders, or known history of active and severe renal, hepatic, respiratory, or cardiac diseases, or known allergy to systemic or local anesthetics or dexmedetomidine
研究组 & 干预措施
saline (Group A)
perineural ropivacaine
干预措施: perineural dexmedetomidine (Drug)
0.5 mcg/kg dexmedetomidine (Group B)
(perineural ropivacaine plus 0.5 mcg/kg dexmedetomidine),
干预措施: perineural dexmedetomidine (Drug)
1 mcg/kg dexmedetomidine (Group C)
(perineural ropivacaine plus 1 mcg/kg dexmedetomidine)
干预措施: perineural dexmedetomidine (Drug)
1.5 mcg/kg dexmedetomidine (Group D)
(perineural ropivacaine plus 1.5mcg/kg dexmedetomidine)
干预措施: perineural dexmedetomidine (Drug)
2 mcg/kg dexmedetomidine (Group E)
(perineural ropivacaine plus 2 mcg/kg dexmedetomidine)
干预措施: perineural dexmedetomidine (Drug)
结局指标
主要结局
Postoperative pain
时间窗: up to 12 hours after brachial plexus blocks
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain, 1-3 representing mild uncomfortable, 4-6 representing moderate pain, 7-10 representing high-level pain or/and uncomfort. The FLACC scale was evaluated at 6 and 12 hours postoperatively, and scale of ≥4 points was regarded as an inadequate analgesia and was managed with 10 mg/kg of ibuprofen by mouth every 6 h as required
the minimum local anesthetic concentration (MLAC)
时间窗: up to 30 minutes after brachial plexus blocks
For each patient, the target concentration of perineural ropivacaine was determined using the modified Dixon's up-and-down method starting with 0.20% in each group, varied with 0.1% as a step size. Increasing or decreasing the target concentration of perineural ropivacaine was determined by the response of the previous child in the same group. The response of each child was observed for 60 s after the skin incision and evaluated as 'successful' or 'unsuccessful.' 'Unsuccessful' was recorded when skin incision caused motor responses or change in hemodynamic parameters (heart rate and mean blood pressure) more than 20% of the preincision values. If the response was determined to be unsuccessful, the concentration of perineural ropivacaine given to the next patient would be increased by 0.1%. If it was successful, the concentration of caudal levobupivacaine given to the next patient would be decreased by 0.1%
The sedation status
时间窗: up to 12 hours after brachial plexus blocks
Sedation status was evaluated by a attending anesthesiologists with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S). The MOAA/S scale was evaluated at 6 and 12 hours postoperatively 0 Does not respond to a noxious stimulus 1. Does not respond to mild prodding or shaking 2. Responds only after mild prodding or shaking 3. Responds only after name is called loudly or repeatedly 4. Lethargic response to name-spoken in normal tone 5. Appears asleep, but responds readily to name-spoken in normal tone 6. Appears alert and awake, responds readily to name-spoken in normal tone
次要结局
- noninvasive arterial blood pressure(up to 12 hours after brachial plexus blocks)
- pulse oximetry(up to 12 hours after brachial plexus blocks)
- heart rate(up to 12 hours after brachial plexus blocks)
研究者
Wenhua Zhang
Director, Clinical Resesearch
Guangzhou Women and Children's Medical Center