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临床试验/NCT01624844
NCT01624844已完成不适用

Predictive Value of an Ultrasound Model of Measurement of the Dural Sac Volume on the Sensory Level Obtained by Spinal Anesthesia

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging

研究概览

简要总结

The purpose of this study is to investigate whether the dural sac volume as determined by a geometrical calculation following multilevel measurements of its transverse area and length by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric bupivacaine in a non-obstetrical population.

详细描述

Sensory block extent may be difficult to predict in spinal anesthesia. Many factors influencing the intrathecal spread have been identified. Among the most important factors is the lumbosacral cerebrospinal fluid (CSF) volume and the dimensions of the dural sac. One study using magnetic resonance imaging (MRI) reported significant correlations between CSF volume and sensory block levels following spinal anesthesia. However, unlike ultrasound imaging, MRI can be difficult to obtain in the surgical setting. Although ultrasound imaging of the lumbar spine may not directly determine the CSF volume, multilevel measurements of the transverse area and length of the dural sac by ultrasound imaging followed by a geometrical calculation of its volume could help predict the extent of the intrathecal spread.

Methods: Patients scheduled for elective surgery under spinal anesthesia will be considered for this study. Ultrasound imaging will be achieved in a non-sterile manner with the patient in the sitting position. Spinal imaging will be performed using a low frequency probe. Focus and gain will be optimized. The first images will be made to identify the inter-laminar spaces from T11 to S1. At each level, the area of the dural sac will be measured in short axis using an adjustable ruler built-in the ultrasound monitor. The middle of the inter-laminar spaces will be marked on the patient's skin and the length of the dural sac will be defined as the distance between the middle of T11-12 and L5-S1. The total volume will be geometrically calculated. The L3-L4 space will be localized by triangulation and marked on the patient's skin as the optimal puncture site for spinal anesthesia. The optimal puncture angle will also be determined.

After placement of standard non-invasive monitoring, spinal anesthesia will be performed using 27-G Pencan needle. After aspiration of CSF, a solution of hyperbaric bupivacaine and fentanyl will be injected over a period of 15 seconds. The dose of bupivacaine will be determined by the attendant anaesthesiologist. The aspiration of CSF will be repeated at the end of the injection. Subsequently, the patient will be placed in supine position.

The extent of sensory block will be assessed by loss of pinprick sensation (using a #5.88 Von Frey filament) and loss of cold sensation to ice every 10 minutes until the same sensory level is observed in two consecutive assessments for a minimum period of 30 minutes. The extent of the block will be assessed bilaterally from caudal to cranial direction in the mid-clavicular line beginning at L3. The investigators will consider the peak sensory level as the uppermost blocked dermatome.

Total amount of crystalloids administered, incidence of significant hypotension and bradycardia will be recorded. Time to perform ultrasound measurements and time to discharge will also be noted. Resolution of the motor block will be assessed using the Bromage score at 3.5 hour, 4 and 4.5 hour following the injection of bupivacaine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting patients aged 18-80 years
  • ASA physical status 1-3

排除标准

  • Contraindication to regional anesthesia (coagulopathy, sepsis or local infection at the site of injection, pre-existing neuropathy in the area involved)
  • Surgery requiring the use of isobaric bupivacaine (0.5%)
  • Allergy to local anesthetics (amide group)
  • Anatomic abnormality of the spine (scoliosis, kyphosis)
  • Previous spinal surgery
  • Patient refusal

结局指标

主要结局

Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging

时间窗: Before spinal anesthesia (Day 0)

次要结局

  • Peak sensory level(From injection of bupivacaine until 30 minutes after injection (Day 0))
  • Time spent for ultrasound imaging measurements(Before spinal anesthesia (Day 0))
  • Duration of motor block(At 3.5, 4 and 4.5 hours following injection of bupivacaine (Day 0))
  • Incidence of side-effects related to spinal anesthesia(From spinal injection of bupivacaine until discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days))
  • Length of stay in the recovery room(From arrival to discharge from the recovery room (Patients will be followed for the duration of stay in the recovery room on the day of surgery, an expected average of one hour))
  • Length of stay in the hospital(From surgery to discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days))

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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