跳至主要内容
临床试验/NCT01877356
NCT01877356终止不适用

Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
time to micturition (minutes)

研究概览

简要总结

The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric Prilocaine with "classical bilateral spinal anesthesia" using plain Prilocaine according to block characteristics and quality of micturition, standardized to the subjects own functional bladder capacity. Our hypothesis is that unilateral spinal anesthesia will provide faster time to micturtition and discharge, lesser hypotension and lesser micturition problems.

详细描述

Many studies have been published in search of the ideal locoregional anesthetic for day case procedures under spinal anesthesia.

Transient neurological symptoms (TNS) and bladder retention are two side effects, which have been described in literature with incidences ranging from 0-80%.

Lidocaine, which was our hospital standard for spinal anesthesia in day case surgery, has a high incidence of TNS. Besides changing the product, dose or additive, optimisation of spinal anesthesia can be performed by changing anesthetic technique or fluid policy.

There is no consensus in literature about fluid policy and the risk of urinary retention. In a previous study we found that urge sensation and bladder capacity is subject to a high variability.

There are a few studies published about unilateral anesthesia for day-case surgery. For bilateral anesthesia it was shown that recuperation of the detrusor function comes with the regression of the sensory block to the S2 dermatome . However, little is known about bladder function during unilateral block of the sacral segments, not to mention the detrusor function and micturition with an asymmetric recovery of the sensory and motor block.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • spinal anaesthesia
  • surgery<60 minutes

排除标准

  • preexisting micturition problems
  • surgery lower abdomen/pelvis
  • mental problems
  • kidney disease
  • neurologic disease

研究组 & 干预措施

bilateral spinal anesthesia

Experimental

bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery

干预措施: bilateral spinal anesthesia (Procedure)

unilateral spinal anesthesia

Experimental

unilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery

干预措施: unilateral spinal anesthesia (Procedure)

结局指标

主要结局

time to micturition (minutes)

时间窗: up to 360 minutes

time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)

regression motor block

时间窗: up to 240 minutes

Motor block will be assessed at regular intervals from spinal injection (t0) until total regression of the motor block.

discharge time ( minutes)

时间窗: up to 360 minutes

time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge

次要结局

  • drop blood pressure(up to 240 minutes)
  • incidence transient neurologic symptoms(1 week)

研究者

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

Dr M. B. Breebaart

dr

University Hospital, Antwerp

研究点 (2)

Loading locations...

相似试验

Comparative Study Between Bilateral and Unilateral... | 临床试验