NCT05726760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 21, 2021

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

August 21, 2021

Last Update Submit

February 10, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Temperature measured on the dorsum of both feet.

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

Secondary Outcomes (2)

  • 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.

Study Arms (2)

Study group - Parturients having spinal anaesthesia

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.

Behavioral: Seeking informed consent for participation in the study.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.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.Device: Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the ear.

Control group - Parturients not having spinal anaesthesia

6 parturients will be recruited as a control group. 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.

Behavioral: Seeking informed consent for participation in the study.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.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.Device: Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the ear.

Interventions

Seeking informed consent for participation in the study.BEHAVIORAL

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.

Control group - Parturients not having spinal anaesthesiaStudy group - Parturients having spinal anaesthesia
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.DEVICE

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

Control group - Parturients not having spinal anaesthesiaStudy group - Parturients having spinal anaesthesia
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.DEVICE

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

Control group - Parturients not having spinal anaesthesiaStudy group - Parturients having spinal anaesthesia
Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the ear.DEVICE

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

Control group - Parturients not having spinal anaesthesiaStudy group - Parturients having spinal anaesthesia

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (9)

  • Werdehausen R, Braun S, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Uniform distribution of skin-temperature increase after different regional-anesthesia techniques of the lower extremity. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):73-8. doi: 10.1016/j.rapm.2006.07.009.

    PMID: 17196496BACKGROUND

  • Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.

    PMID: 29938773BACKGROUND

  • Park SY, Nahm FS, Kim YC, Lee SC, Sim SE, Lee SJ. The cut-off rate of skin temperature change to confirm successful lumbar sympathetic block. J Int Med Res. 2010 Jan-Feb;38(1):266-75. doi: 10.1177/147323001003800131.

    PMID: 20233538BACKGROUND

  • Bengtsson M. Changes in skin blood flow and temperature during spinal analgesia evaluated by laser Doppler flowmetry and infrared thermography. Acta Anaesthesiol Scand. 1984 Dec;28(6):625-30. doi: 10.1111/j.1399-6576.1984.tb02134.x.

    PMID: 6240882BACKGROUND

  • Penno A, Arumugam M, Antweiler G, Laubert T, Habermann J, Bruch HP. [Increase in skin surface temperature in spinal anesthesia. Predictive value for probability of surgical tolerance]. Anaesthesist. 2012 Sep;61(9):770-6. doi: 10.1007/s00101-012-2076-3. Epub 2012 Sep 8. German.

    PMID: 22955888BACKGROUND

  • Jetzek-Zader M, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Increase in skin temperature after spinal anesthesia in infants. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):519-22. doi: 10.1016/j.rapm.2006.07.007.

    PMID: 17138194BACKGROUND

  • Ehrlich PF, Vedulla G, Cottrell N, Seidman PA. Monitoring intraoperative effectiveness of caudal analgesia through skin temperature variation. J Pediatr Surg. 2003 Mar;38(3):386-9. doi: 10.1053/jpsu.2003.50113.

    PMID: 12632354BACKGROUND

  • Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998 Jul-Aug;23(4):418-23. doi: 10.1016/s1098-7339(98)90017-7.

    PMID: 9690596BACKGROUND

  • Griffin RP, Reynolds F. The association between foot temperature and asymmetrical epidural blockade. Int J Obstet Anesth. 1994 Jul;3(3):132-6. doi: 10.1016/0959-289x(94)90224-0.

    PMID: 15636935BACKGROUND

Study Officials

  • Laura Kessack, MBChB2003

    Cambridge University Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kessack, MBChB MRCP (UK) FRCA

CONTACT

01223 217642laura.kessack@nhs.net

Stephen Kelleher

CONTACT

01223 217418research@addenbrookes.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

August 21, 2021

First Posted

February 14, 2023

Study Start

August 21, 2021

Primary Completion

March 21, 2023

Study Completion

May 21, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)