跳至主要内容
临床试验/NCT03410888
NCT03410888已完成不适用

Popliteal Approach to Sciatic Nerve Block Provides Postoperative Analgesia That Is Not Inferior to That of the Infragluteal Approach in Patients Undergoing Unilateral Total Knee Arthroplasty Under Spinal Anesthesia

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Visual analogue pain scores. The score at 6 hours will be considered as primary outcome.

研究概览

简要总结

Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a clinically significant difference in pain visual analogue sores (VAS) between the analgesia provided by the popliteal block and that of the infragluteal sciatic block in TKA surgery patients.

详细描述

Sciatic nerve block provides clinically significant analgesic benefits following total knee arthroplasty (TKA). These benefits include a reduction in pain scores and decrease analgesic requirements.

Despite these benefits, sciatic nerve block has remained among the least performed peripheral nerve block by anesthesiologists. Some impediments relating to single shot sciatic nerve block (SSNB) that may cause anesthesiologists to avoid it include, patient discomfort due to needle passage through dense gluteal or thigh adipose and musculature, and unreliable success because of difficulty in localizing the sciatic nerve (particularly in obese patients).

Even in the current era of US guidance, sciatic nerve block remains a challenge. Despite its helpfulness, ultrasound technology remains hindered by an intrinsic limitation: a trade off between depth of penetration and image resolution; therefore, it works well for superficial blocks but becomes less useful when deep structures are imaged-ironically where this guidance is needed most. The challenge of anatomical depth, as in the case of the sciatic nerve, is one remaining challenge that dictates practical restrictions on the patterns of practice of ultrasound-guided regional anesthesia.

Actually, the recommendations of the Joint Committee for Education and Training composed of the American Society of Regional Anesthesia and the European Society of Regional Anesthesia cite the depth of block resulting in degradation of both ultrasound and needle image as the first among other causes that increase the level of difficulty of a nerve block.

As the sciatic nerve travels caudally in the body, it becomes more superficial with less thickness of tissue separating it from skin surface, making distal sciatic nerve block an attractive alternative. Indeed, both articular branches which provide sensory innervation to the knee joint as well as its muscular branches which provide innervation to the muscles surrounding knee joint most commonly arise from the sciatic nerve either at the knee level, or just above the knee or within the popliteal fossa.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • American Society of Anesthesiologists (ASA) Physical Status Scale I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
  • Ages 18-85
  • BMI ≤ 38 kg/m2

排除标准

  • Chronic pain disorders
  • Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
  • Abuse of drugs or alcohol
  • Allergies to any medication included in the study protocol
  • Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
  • Bilateral TKA surgeries
  • History of significant psychiatric conditions that may affect patient assessment
  • Pregnancy

研究组 & 干预措施

popliteal approach

Experimental

Blockade of the sciatic nerve at the level of the popliteal fossa.

干预措施: Popliteal approach (Procedure)

infragluteal approach

Active Comparator

Blocking the sciatic nerve at the subgluteal level.

干预措施: Infragluteal approach (Procedure)

结局指标

主要结局

Visual analogue pain scores. The score at 6 hours will be considered as primary outcome.

时间窗: 6 hours

Overall pain level as well as pain localized o the back of the knee will be assessed at rest and on movement (knee flexion) and will be quantified with a 100 mm VAS pain scale score, with 0 representing no pain and 100 representing the worst imaginable pain.

次要结局

  • Sensory/Motor block onset assesment in the sciatic nerve distribution(60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验