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AnesthesiaNCT05726760

Peripheral Skin Temperature Changes Following Spinal Anaesthesia for Category 4 LSCS

An observational study of Anesthesia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Seeking informed consent for participation in the study., 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. and 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.
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
21 Aug 2021to 21 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • Parturients with hypertensive disorders of pregnancy
  • ASA 3+ Parturients
  • BMI >40 or <18
  • Parturient refusal.

Trial locations and contacts

1 site in 1 country.

Laura Kessack, MBChB MRCP (UK) FRCA contact

01223 217642

laura.kessack@nhs.net

United Kingdom1 site, 1 recruiting
  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

    Adam Loveday, 01223 348466, adam.loveday@addenbrookes.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Tympanic temperature will be measured by a Braun Welch Allyn tympanic membrane thermometer device before spinal anaesthesia and then every 30 minutes until the end of surgery as per NICE clinical guideline 65.

Spinal anaesthesia will be conducted as per usual practice. All intravenous fluids will be given through a fluid warmer.

Parturient data to be recorded will include: Age, Weight, Height, BMI, total dose of intra-operative vasopressor given, highest estimated dermatome level of anaesthesia to cold (ethyl chloride spray) bilaterally prior to commencing surgery, level motor block using straight leg raise as per normal practice when anaesthesia ready for surgery, duration of surgery, estimated blood loss, total volume of intravenous fluids given (including any blood products). Dermatome level of anaesthesia will be measured to cold (ethyl chloride spray) level and motor block will be measured using straight leg raise as per normal practice, in recovery, every 30 minutes.

6 parturients will be recruited as a control group. The skin temperature of these 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 in theatre. The temperature will be measured by Covidien Mon-a-Therm skin temperature probes and a Braun Welch Allyn tympanic membrane thermometer device. The sterile drapes will be applied and 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 for 30 minutes. After 30 minutes, 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 for 5 minutes. Theatre room temperature will be measured and recorded for this control group of parturients. The ambient temperature under the surgical drapes will be measured and recorded using a room thermometer.

Inclusions / exclusions:

Parturients will be excluded from the study if the parturient refuses or if they have medical conditions that may affect peripheral temperature and therefore the results of the study. The exclusion criteria are: 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); Hypertensive disorders of pregnancy; ASA 3+ Parturients; BMI >40 or <18; Parturient refusal.

Conditions
Anesthesia
Being tested
Seeking informed consent for participation in the study., 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., 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., Temperature measurement by Braun Welch Allyn tympanic membrane thermometer device to the ear.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seeking informed consent for participation in the study.Behavioural

    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.

  • 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.

  • 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.

  • 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.

Study groups in NCT05726760
Study groupRoleWhat they receive
Study group - Parturients having spinal anaesthesiaASA 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.
Receives: 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 anaesthesia6 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.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Measurement of peripheral temperature using the Infra red tympanic thermometer.

    Infra red tympanic thermometers measure the frequency of infrared light emitted by the tympanic membrane. The investigators propose that infra red tympanic thermometers could also be used to measure the frequency of infrared light emitted by the skin.

    Measured: During the spinal anaesthetic and lower segment caesarean section in theatre and for the 2 hours the parturient is in the recovery area.

  2. 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.

    Temperature measured on the dorsum of both feet.

    Measured: During the 2 hours the parturient is in the recovery area.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start21 Aug 2021
  3. Primary completion21 Mar 2023 (estimated)
  4. Study completion21 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726760
Sponsor's protocol ID
IRAS263967
Status last verified
Feb 2023
First submitted
21 Aug 2021
Last updated
14 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17196496
  • 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.

    PubMed 29938773
  • 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.

    PubMed 20233538
  • 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.

    PubMed 6240882
  • 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.

    PubMed 22955888
  • 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.

    PubMed 17138194
  • 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.

    PubMed 12632354
  • 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.

    PubMed 9690596
  • 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.

    PubMed 15636935
  • Kessack L, Davenport G, McGlennan C, Bamber JH. Observational study of peripheral skin temperature changes following spinal anaesthesia for caesarean birth. Int J Obstet Anesth. 2024 May;58:103970. doi: 10.1016/j.ijoa.2023.103970. Epub 2023 Dec 13.

    PubMed 38485585

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laura Kessack, MBChB MRCP (UK) FRCA (01223 217642, laura.kessack@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726760, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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