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NCT05726760
Peripheral Skin Temperature Changes Following Spinal Anaesthesia for Category 4 LSCS
trial testing Seeking informed consent for participation in the study. in Anesthesia in 66 participants. Status unknown.
21 March 2023
Quick facts
| Lead sponsor | Cambridge University Hospitals NHS Foundation Trust |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 66 |
| Start date | 21 August 2021 |
| Primary completion | 21 March 2023 |
| Estimated completion | 21 May 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions 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.
Conditions studied
- Anesthesia — all drugs for Anesthesia →
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Who can join
Adults 18 to 60, female only, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05726760
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05726760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cambridge University Hospitals NHS Foundation Trust
- Last refreshed: 14 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05726760.
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