Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Differences in Time to Resolution 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), leads to longer anesthesia and analgesia of the leg.
Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported.
The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.
详细描述
This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.
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 signs of neuropathy in the ipsilateral 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 of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Perineural Injection for Subgluteal Sciatic Nerve Block (Procedure)
Perineural
Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Femoral Nerve Block (Procedure)
Perineural
Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Patient-controlled postoperative analgesia (Procedure)
Perineural
Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Mepivacaine (Drug)
Intraneural
Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Intraneural Injection for Subgluteal Sciatic Nerve Block (Procedure)
Intraneural
Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Femoral Nerve Block (Procedure)
Intraneural
Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Patient-controlled postoperative analgesia (Procedure)
Intraneural
Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
干预措施: Mepivacaine (Drug)
结局指标
主要结局
Differences in Time to Resolution of Sciatic Nerve Block
时间窗: <12 h
The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria: * Sensory: patients feel discomfort when pricked with a thin needle (25G) * Motor: patients may move both toes and ankle, albeit with reduced strength This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.
次要结局
- Success Rate of Anesthetic Nerve Blocks(≤30 min)
- Incidence and Prevalence of Neurologic Disturbances(30 days)
- Block Onset Time(≤30 min)
研究者
Marco Baciarello
Assistant Professor, Anesthesia, Critical Care and Pain Medicine
University of Parma