Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Onset Time of Sciatic Nerve Block
研究概览
简要总结
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg.
The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. They will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery.
The safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.
详细描述
This will be a randomized, controlled, patient- and observer-blinded trial assessing block characteristics after intra- or perineural injection of ropivacaine for subgluteal sciatic nerve blocks performed for elective surgery of the lower limb.
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
- Triple (Participant, Care Provider, 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
- •Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
- •ASA Physical Status Class I-III
- •Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)
排除标准
- •Unable to understand or communicate for the purpose of the study
- •Exhibiting any neurological disturbance of the ipsilateral lower extremity
- •Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
研究组 & 干预措施
Perineural
Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Perineural Injection for Subgluteal Sciatic Nerve Block (Procedure)
Perineural
Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Femoral Nerve Block (Procedure)
Perineural
Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Patient-Controlled Postoperative Analgesia (Procedure)
Perineural
Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Ropivacaine (Drug)
Intraneural
Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Intraneural Injection for Subgluteal Sciatic Nerve Block (Procedure)
Intraneural
Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Femoral Nerve Block (Procedure)
Intraneural
Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Patient-Controlled Postoperative Analgesia (Procedure)
Intraneural
Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Onset Time of Sciatic Nerve Block
时间窗: ≤30 minutes after block performance
Time to onset of sciatic nerve anesthesia, defined as both following criteria: * Sensory: does not feel pain or discomfort when pricked with a 25G needle. * Motor: able to slightly curl toes; unable to flex the ankle.
次要结局
- Success Rate of Sciatic Nerve Blocks(≤30 min after block performance)
- Incidence and Prevalence of Neurologic Disturbances(30 days after anesthesia performance)
- Differences in Time to Resolution of Sciatic Nerve Block(<12 h)
研究者
Marco Baciarello
Assistant Professor of Anesthesiology, Critical Care and Pain Medicine
University of Parma