The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks Following Oromaxillofacial Reconstruction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the duration of sensory blocks
研究概览
简要总结
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. In Group Ropivacaine (Group R), nerve blocks were administered with 0.3% ropivacaine. In Group Ropivacaine + Dexmedetomidine (Group RD), nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, SpO2, sedation level, the duration of motor blocks.
详细描述
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. For patients with free fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with anterolateral thigh flaps harvested, femoral nerve block with ropivacaine was administered.In Group R, nerve blocks were administered with 0.3% ropivacaine. In Group RD, nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, pulse oxygen saturation (SpO2), sedation level, the duration of motor blocks.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of oral and maxillofacial tumor.
- •Undergoing microsurgical oromandibular reconstruction with free fibular flaps or anterolateral thigh flaps.
- •Greater than 18 years old.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •True allergy to local anesthetics or dexmedetomidine.
- •History of chronic pain on opioids within the last 12 months.
- •Specific mental health issues such as schizophrenia or bipolar disorder.
- •Patients who are pregnant.
研究组 & 干预措施
Group R
Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine.
干预措施: Ropivacaine (Drug)
Group RD
Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
干预措施: 0.3% ropivacaine and 50 μg dexmedetomidine (Drug)
结局指标
主要结局
the duration of sensory blocks
时间窗: The duration of sensory blocks was recorded up to 48 hours after injection.
The duration of sensory block was defined as the time interval between the end of ropivacaine administration and the pain score up to 5.
次要结局
- heart rate(every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours)
- sedation level(every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours)
研究者
Xiaofeng Bai
Associate Professor
China Medical University, China