跳至主要内容
临床试验/NCT05726760
NCT05726760招募中不适用

Observational Study of Peripheral Skin Temperature Changes Following Spinal Anaesthesia for Category 4 Lower Segment Caesarean Section (LSCS)

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
The peripheral skin temperature of the dorsum of the feet measured prior to and following establishment of a spinal anaesthetic block in parturients undergoing category 4 caesarean section.

研究概览

简要总结

Regional anaesthesia of the lower limbs blocks sympathetic nerve fibres as well as sensory and motor fibres. It has been documented previously in the non-pregnant population that the blockade of sympathetic nerve fibres by regional anaesthesia (including spinal, epidural and lumbar plexus anaesthesia) results in vasodilation of peripheral blood vessels and an increase in the blood flow to the skin, increasing the peripheral skin temperature. Additionally thermoregulation has been found to be impaired more by spinal anaesthesia than epidural anaesthesia. The aim of the study is to measure peripheral skin temperature changes occurring in the lower limbs following spinal anaesthesia in the pregnant obstetric population undergoing category 4 lower segment caesarean section. The hypothesis is that peripheral skin temperature will rise following spinal anaesthesia and that this temperature change could be used as a measure of bilateral sympathetic block which may be an indicator of potential success of spinal anaesthesia. Future follow up studies could then potentially determine if peripheral skin temperature can also be used as a marker to determine the success of epidural analgesia for labour.

The study will involve temperature measurement by Covidien Mon-a-Therm skin temperature probes and Braun Welch Allyn tympanic membrane thermometer devices on the dorsum of the right and left feet. The study will last from the time the parturient arrives in theatre for their lower segment caesarean section until the parturient leaves the recovery area.

详细描述

The hypothesis is that peripheral skin temperature will rise following spinal anaesthesia and that this temperature change could be used as an indicator of potential success of spinal anaesthesia.

This is an observational study. The investigators will obtain ethics committee approval for conducting the study. ASA 1 and 2 full term (37-42 weeks), parturients with singleton pregnancy, normal placental position, scheduled for category 4 LSCS under 'single-shot' spinal anaesthesia will be recruited. The investigators intend to recruit 60 parturients. The parturients will undergo an informed consent process including an explanation of the methods and risks of the study. A patient information leaflet will be provided for the parturients.

The data will be collected on a password protected spread-sheet with no patient identifiable information. A grant for funding has been granted from the Obstetric Anaesthetists' Association.

Prior to establishment of spinal anaesthesia, the skin temperature of the parturient's feet will be measured on the dorsum of the right and left feet above space between the 2nd and 3rd metatarsal bones while the parturient is lying supine with left lateral tilt. The temperature will be measured by Covidien Mon-a-Therm skin temperature probes and a Braun Welch Allyn tympanic membrane thermometer device. Following spinal injection when the parturient is lying supine with lateral tilt, the temperature will be re-measured by Covidien Mon-a-Therm skin temperature probes and a Braun Welch Allyn tympanic membrane thermometer device. The skin temperature of the parturient's feet will be monitored continuously by the Covidien Mon-a-Therm skin temperature probes using the GE Healthcare monitor with readings transcribed every 1 minute by the research investigator until transfer onto the bed at the end of surgery. The skin temperature of the parturient's feet will be measured and recorded every 1 minute using a Braun Welch Allyn tympanic membrane thermometer device until the sterile drapes are applied prior to commencing the operation and then again after removal of the drapes prior to transfer onto the bed. Following transfer to the post-operative recovery area, the skin temperature of the parturient's feet will be measured and recorded every 10 minutes using a Braun Welch Allyn tympanic membrane thermometer device until discharged to the ward from the recovery area (usually 2 hours from departmental guidelines).

Theatre room temperature will be measured and recorded at the start of anaesthesia and at the end of surgery using a room thermometer. Surgical drapes will be applied over the parturient's lower limbs during the caesarean section procedure as per the investigators routine practice. The ambient temperature under the surgical drapes will be measured and recorded at the start of anaesthesia and at the end of surgery using a room thermometer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Full term (37-42 weeks) parturients
  • •ASA 1 and 2
  • •Singleton pregnancy
  • •Normal placental position
  • •Scheduled for category 4 LSCS
  • •'Single-shot' spinal anaesthesia
  • •Signed informed consent
  • •Received a patient information leaflet

排除标准

  • •Any medical conditions that may affect peripheral temperature
  • •Parturients converted to other forms of anaesthesia (not just spinal anaesthesia)
  • •Parturients with a pyrexia / sepsis
  • •Parturients with peripheral vascular disease (including Raynauds)
  • •Parturients with cardiovascular disease
  • •Parturients with diabetes mellitus (gestational, type 1 or 2)
  • •Parturients with hypertensive disorders of pregnancy
  • •ASA 3+ Parturients
  • •BMI >40 or <18
  • •Parturient refusal.

结局指标

主要结局

The peripheral skin temperature of the dorsum of the feet measured prior to and following establishment of a spinal anaesthetic block in parturients undergoing category 4 caesarean section.

时间窗: During the spinal anaesthetic inserted for the lower segment caesarean section in theatre

Temperature measured on the dorsum of both feet.

次要结局

  • Measurement of peripheral temperature using the Infra red tympanic thermometer.(During the spinal anaesthetic and lower segment caesarean section in theatre and for the 2 hours the parturient is in the recovery area.)
  • The peripheral skin temperature of the dorsum of the feet measured in recovery following establishment of a spinal anaesthetic block in parturients undergoing category 4 caesarean section.(During the 2 hours the parturient is in the recovery area.)

研究者

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

Dr Laura Kessack

Consultant Anaesthetist

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

Loading locations...

相似试验

Peripheral Skin Temperature Changes Following Spinal... | 临床试验