Peripheral Skin Temperature Changes Following Spinal Anaesthesia for Category 4 LSCS

NCT05726760 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2023-02-14

No results posted yet for this study

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.

Conditions

  • Anesthesia

Interventions

BEHAVIORAL

Seeking informed consent for participation in the study.

The parturients will undergo an informed consent process including an explanation of the methods and risks of the study. The Anaesthetist or researcher will conduct this process. A patient information leaflet will be provided for the parturients.

DEVICE

Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the dorsum of the right and left feet above space between the 2nd and 3rd metatarsal bones.

The Anaesthetist or researcher and recovery nurse will conduct the intervention in theatre and in the recovery ward.

DEVICE

Covidien Mon-a-Therm skin temperature probes will be applied to the dorsum of the right and left feet above space between the 2nd and 3rd metatarsal bones.

The Anaesthetist or researcher will conduct the intervention in theatre. The probes will be removed in the recovery ward.

DEVICE

Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the ear.

The Anaesthetist or researcher and recovery nurse will conduct the intervention in theatre and in the recovery ward.

Sponsors & Collaborators

  • Obstetric Anaesthetists' Association United Kingdom

    collaborator OTHER
  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Laura Kessack, MBChB2003 · Cambridge University Hospitals

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-21
Primary Completion
2023-03-21
Completion
2023-05-21

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726760 on ClinicalTrials.gov