Skip to main content
Clinical Trials/NCT05726760
NCT05726760RecruitingNot Applicable

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

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country66 target enrollmentStarted: August 21, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
66
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: During the spinal anaesthetic inserted for the lower segment caesarean section in theatre

Temperature measured on the dorsum of both feet.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Laura Kessack

Consultant Anaesthetist

Cambridge University Hospitals NHS Foundation Trust

Study Sites (1)

Loading locations...

Similar Trials

Peripheral Skin Temperature Changes... | Clinical Trial