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临床试验/NCT03450798
NCT03450798已完成不适用

SOFT Block Versus Spinal Anesthesia in Patients Undergoing Surgery for Fixation of Open Tibial Fractures Using Ilizarov External Fixator

Ain Shams University2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2018年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
T- test of the recovery time(duration of analgesia)mean±SD

研究概览

简要总结

Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral site of the surgical procedure and the ability to block pain pathways at multiple levels. On the contrary to other anesthetic techniques, as spinal or general anesthesia, properly performed peripheral nerve blocks bypass adverse events as hemodynamic instability and respiratory complications, properly treat post-operative pain leading to early hospital discharge. Additional advantages of peripheral nerve blocks are that they can be used in patients receiving anti-coagulants or lumbosacral disease in addition to avoidance of airway instrumentation.

Recently, there has been a significant interest in regional anesthesia and peripheral nerve blockade. This is facilitated by a significant advance of the research in this field and availability of better equipment facilitating regional anesthesia.The aim of this study was to assess the efficacy and safety of SOFT block (sciatic-obturator-femoral nerve block technique) in comparison with spinal anesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator.

详细描述

After the approval of medical ethical committee of Ain Shams University, this prospective parallel group double blinded study will be conducted over 60 patients between the age of 35-57 years old, ASA physical status I and II, scheduled for fixation of open tibial fractures using iIlizarov external fixator. at Ain Shams University hospitals in 2018-2019, After written informed consent is obtained.

Refusal to participate, inability to communicate with the investigators or hospital staff, obesity (body mass index>40 kg/m2), patients undergoing bilateral surgery, patients with coagulopathies ,renal insufficiency (creatinine>1.5 mg/dL), American Society of Anesthesia (ASA) III-IV, patients with any contraindication to regional anesthesia , patients with unstable vital data and patients with head or chest trauma will be excluded.

Preanesthetic check will be done at night of surgery. After an intravenous (IV) cannula will be secured , and midazolam 0.05 mg/kg i.v. will be given to all patients before transfer to the operating room where standard monitoring devices as ECG,Non invasive blood pressure and pulse oximetry will be placed. Then, patients will be randomly allocated by sealed envelope technique to receive either spinal anesthesia or SOFT block. In spinal anesthesia group, patients will receive spinal anesthesia with hyperbaric bupivacaine 0.5% (7.5-10mg). This will be administered via a 25-G spinal needle at L4-L5 or L3-L4 with the patient in the sitting position under complete aseptic conditions.

In SOFT group, patients will receive SOFT block where patients will be positioned in supine position,under aseptic conditions, a linear US probe will be placed on the inguinal crease to show the femoral nerve and vessels. Using an in-plane technique, a 12-cm stimulating block needle will be introduced medial to the femoral vein and advanced 1-3 cm below and parallel to the skin. Then, It will be redirected toward the fibres of the femoral nerve, where 15 mL of bupivacaine 0.25% will be injected. To block the obturator nerve, the probe will be shifted medially, superior to the needle, and directed cranially to identify the pectineus muscle . The needle will be then withdrawn to the subcutaneous tissue and redirected using an out-of-plane technique toward the deep surface of the pectineus, where 10 mL of bupivacaine 0.25%will be injected.[4 ] To locate the sciatic nerve, we will use the curvilinear probe, directed it inferior to the needle, and tilted the probe to get the clearest image of the sciatic nerve.The needle will be inserted then withdrawn subcutaneously and directed by an in-plane technique toward the sciatic nerve deep to the inferior border of the quadratus femoris muscle. Then 20 mL of bupivacaine 0.25% will be injected after needle elicited muscle twitches using 1 mA current.

Sensory level will be evaluated by loss of pinprick sensation (20-gauge hypodermic needle).

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
None

入排标准

年龄范围
35 Years 至 57 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 35 to 57 years old
  • fixation of open tibial fractures using Ilizarov external fixator -

排除标准

  • Refusal to participate,
  • Inability to communicate with the investigators or hospital staff,
  • body mass index>40 kg/m2
  • patients undergoing bilateral surgery,
  • History of coagulopathies
  • creatinine>1.5 mg/dL
  • American Society of Anesthesia (ASA) III-IV
  • Any contraindication to regional anesthesia
  • Unstable vital data
  • Head or chest trauma will be excluded.

结局指标

主要结局

T- test of the recovery time(duration of analgesia)mean±SD

时间窗: 3-12 hours

It is the time from the end of local anaesthetic injection to complete resolution of sensory block

次要结局

  • Failure of the block(50 minutes)
  • Review of medical records for postoperative complications(48 hours after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hoda Shokri

HShokri

Ain Shams University

研究点 (2)

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