The Clinical Evaluation of a Novel Ultrasound Probe to Guide the Insertion of Central Regional Anaesthesia Using a Regional Anaesthetic Needle Modified to Aid Insertion Under Ultrasound Guidance in Morbidly Obese Women Undergoing Elective Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- The primary end point will be time taken to insert an epidural catheter.
研究概览
简要总结
The study will establish whether the use of ultrasound scanning with a purpose built probe will aid the insertion of the needles for epidural and spinal anaesthesia for obese women undergoing elective caesarean section The study group will be 46 obese women (defined by the ratio of height to weight) at time of initial booking ultrasound scan, undergoing routine caesarean section with no serious illnesses that are both willing and able to provide informed consent prior to spinal epidural anaesthesia. Patients will be excluded if they have signs or symptoms of systemic or local infection, if they have a history of previous spinal surgery, a blood clotting abnormities.
In order to evaluate the clinical usefulness of the ultrasound probe a randomised comparison of the traditional clinical methods of feeling the bones of the spine and ultrasound guided insertion of a combined spinal epidural anaesthetic will be undertaken. The rodiera tiped 17/18G 90mm tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt will be the regional needles used for the combined spinal epidural anaesthetic. Randomisation into two groups (ultrasound guided needle insertion and feeling the bones) will be by computer generated random sequence. This information will be recorded in sealed envelopes and placed in the ward. Patients who meet the inclusion criteria and who consent immediately prior to caesarean section will be sequentially assigned a number that will correspond to a sealed envelope. The main aim of the study will be to detect any difference in time taken to insert epidural catheter via the needle in the patients back. The other factors measured will be the number of times the skin is punctured and bone touched by the needle, number of conversions from regional (spinal epidural) to general anaesthesia, patient satisfaction scores, requirement for extra local anaesthetic following initial blockade during Caesarean section.
The factors will be compared by student t-test using Statistica6 (StatSoft,Inc.(2001). STATISTICA (data analysis software system), version 6. www.statsoft.com). A population of 46 patients will be required assuming a mean time for inserting a combined spinal epidural without
详细描述
Study objective:
The clinical evaluation of a novel ultrasound probe to guide the insertion of central regional anaesthesia using a regional anaesthetic needle modified to aid insertion under ultrasound guidance in morbidly obese women undergoing elective caesarean section. - (full title) The clinical evaluation of a novel ultrasound probe-(short title)
Background and Rationale:
Cases of trauma to the conus medularis following spinal anaesthesia have been highlighted recently by Reynolds1. A second report in the same vein described the inaccuracy of using Tuffier's line between the iliac crests to identify a safe lumbar interspace2. As suspected by many clinicians, precise lumbar interspace identification by palpation is prone to error. Broadbent2 et al confirmed this showing that anaesthetists were only 29% accurate, as determined by MRI/ (Ultrasonography was not investigated by Broadbent). The inaccuracy was corroborated by Furness et al3. who showed that clinical identification by anaesthetists using palpation was 30% accurate, as assessed by lumbar spine X-ray. In contrast, in the latter study, placement of markers using ultrasonography at L3-4 interspace was 71% accurate, a figure which is comparable with the 76% accuracy in the preliminary study described below . It should be noted in the Furness study that ultrasonography was performed by a consultant radiologist but in our study an anaesthetist performed the procedure. The Broadbent and Furness studies both documented that identification by anaesthetists using palpation was often inaccurate by two, three or four interspaces. Using ultrasound, in both the Furness3 study and our study, markers were always within one interspace of the intended position.
Morbid obesity is an increasingly prevalent problem in obstetric practice. Landmarks are often impalpable in obese patients making insertion of epidurals problematic. Thus there is clear clinical need to develop a safe efficient way to administer epidural anaesthesia. The central hypothesis of our application is that ultrasonic visualisation of the landmarks will aid insertion. Further it is possible to develop and manufacture a probe for general use by anaesthetists that will improve current clinical practice in this problematic area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective Caesarean section > 38/52 gestation
- •BMI at booking scan (circia 13/52 gestation)>=35
- •ASA = 1,2 or 3 patients only
排除标准
- •Abnormal clotting screen (coagulopathy) or thrombocytopenia ( < 100,000)
- •Unable to give informed consent to combined spinal epidural anaesthesia
- •Previous spinal surgery or known spinal pathology
- •Signs, symptoms or laboratory evidence of local infection or systemic sepsis
结局指标
主要结局
The primary end point will be time taken to insert an epidural catheter.
时间窗: During the c-section
次要结局
- Patient satisfaction scores immediately post op and at 30 minutes post op(30mins post operatively)
- The number of times the skin is punctured(anaesthesia induction)
- The number of times the cortex of bone touched by the epidural needle(anaesthesia induction)
- The number of conversions from regional (central-neuraxial) to general anaesthesia(anaesthesia induction)
- The volume and concentration of supplementary local anaesthetic administration following primary spinal blockade during caesarean section(intraoperatively)
- Number of needle advancements(Induction of anaesthesia)
- Number of conversions to general anaesthesia(induction of anaesthesia)
- Number of 'dry spinal taps'(induction of anaesthesia)
