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临床试验/CTRI/2023/03/050911
CTRI/2023/03/050911尚未招募3 期

Ultrasound-guided supine popliteal sciatic nerve block: Crosswise approach to popliteal sciatic (CAPS) versus Posterior approach

PGIMER Chandigarh1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年1月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Time to perform the block

研究概览

简要总结

Popliteal sciatic nerveblock (PSNB) is commonly practised regional anaesthesia and analgesia techniquefor below-knee surgeries. It is used alone or combined with a femoral orsaphenous nerve block. The block can be performed blindly, guided by a nervestimulator or ultrasound. The blind landmark-based technique is not preferreddue to lower efficacy and higher complication rates.1 The use ofultrasound (USG) allows a real-time visualisation and delivery of themedication at the target site, improving precision, accuracy and safety. Thenerve block can be performed in the posterior, lateral and supine positions.Lateral and prone may pose challenges in morbidly obese, pregnant, hemodynamicallyunstable and/or spinal injury patients.2 In supineposition, the popliteal sciatic block can be performed by the posteriorapproach with out-of-plane needle entry, lateral or medial approach withlateral or medial in-plane needle entry respectively. The supine posteriorout-of-plane approach provides the advantage of patient comfort, less chance ofpuncturing the popliteal vessels and shorter needle path.3, 4

Recently, Mistry et alhave described an USG-guided CAPS (Crosswise approach to popliteal sciatic)block in a case series of 5 patients successfully with the advantage of betterpatient comfort as there is no need of patient positioning, flexion of hip andknees and external assistance.2

We aim to compare theUSG-guided posterior approach of popliteal sciatic block and CAPS block.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients between age group 18-80 years undergoing below knee surgeries, ASA physical status I-III.

排除标准

  • Patient refusal for nerve blocks, Allergy to amide local anaesthetic drugs, Chronic opioid therapy (>60 mg morphine daily or equivalent), Patients with thrombocytopenia/coagulopathy, on anti-coagulant and thrombolytic therapy, Morbid obesity (BMI>35 with obesity symptoms or BMI > 40), Neurological diseases, Local or systemic infection, Patients with psychiatric illness.

结局指标

主要结局

Time to perform the block

时间窗: (time interval from the contact of USG probe with the patient to the end of local anaesthetic injection)

次要结局

  • 3.Level of procedure related pain(During performance of procedure)
  • 7.48 hour rescue analgesic consumption(during 48 hr follow up)
  • 1. Block onset time(time interval from the end of local anaesthetic injection to the achievement of complete sensory blockade of both saphenous and sciatic nerve)
  • 2.Number of needle passes(During performance of procedure)
  • 4.Sciatic nerve visibility score and depth from skin(During performance of procedure)
  • 5.Visual analog scale (VAS) scores(immediate post-operation (T1), at 2 hours (T2), 4 hours (T3), 8 hours (T4), 12 hours (T5), 16 hours (T6), 24 hours (T7), and 48 hours (T8))
  • 6.Time to first rescue analgesia(during 48 hr follow up)
  • 8.Occurrence of any adverse events/complications(during 48 hr follow up)

研究者

申办方类型
Research institution

研究点 (1)

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