AzTrials
AzTrials

AnesthesiaNCT06596486

A Comparison of CoolStick With Ethyl Chloride for the Assessment of Light Touch

An observational study of Anesthesia, run by Barts & The London NHS Trust at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main aim of this study is to compare CoolStick to ethyl chloride spray for the assessment of light touch following neuraxial anaesthesia for caesarean delivery. Coolstick and ethyl chloride will also be compared for the assessment of cold sensation. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anesthesia
What is being tested?
CoolStick, Ethyl Chloride and Question
How many people
64 participants
Where
3 sitesUnited Kingdom
Study dates
1 Apr 2025to 29 Jan 2026
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 years and older
  • Women only
  • Adult, Older adult

Study population: All eligible patients presenting for elective caesarean section will be invited to participate in the study.

Who may be able to join

  • Pregnant patients presenting for elective caesarean section under spinal or combined spinal-epidural anaesthesia.

Who cannot join

  • < 18 years old
  • Unwilling or unable to give informed consent
  • Inability to understand written and/or verbal English
  • Allergy to stainless steel
  • Allergy to ethyl chloride spray

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites
  • Newham University Hospital

    London

  • The Royal London Hospital

    London

  • Whipps Cross University Hospital

    London

Other trials in United Kingdom

About this study

Official title: A Comparison of CoolStick and Ethyl Chloride Spray for the Assessment of Sensory Block to Light Touch and Cold Before Caesarean Section Under Spinal or Combined Spinal-epidural Anaesthesia

The main aim of this study is to compare CoolStick to ethyl chloride spray for the assessment of light touch following neuraxial anaesthesia for caesarean delivery.

Coolstick and ethyl chloride will also be compared for the assessment of cold sensation.

Participants will also be asked whether they experienced any intraoperative pain.

Read the detailed description

In England, up to 35% of deliveries in 2022 were by caesarean section. Current guidelines from NICE recommend that regional anaesthesia is offered for caesarean section. Neuraxial anaesthesia is considered to carry less risk of morbidity than general anaesthesia for both mother and neonate and is performed for approximately 92% of caesarean sections. To ensure the comfort of the mother, and to avoid intraoperative pain that could lead to general anaesthesia conversion, the neuraxial block is tested prior to commencing surgery. In the United Kingdom, the Royal College of Anaesthetists recommend that less than 1% of elective caesarean sections started under regional anaesthesia are converted to general anaesthesia.

Surveys of UK anaesthetists have found a wide range of practices when assessing neuraxial block, including the testing of light touch, temperature, pain and motor block. In a survey of UK anaesthetists, cold has been shown to be the most widely used modality for testing with 92% of respondents testing this modality. This was followed by touch, which 60% of respondents tested for. Recent consensus guidance from the Obstetric Anaesthetists' Association has recommended light touch as the primary testing modality for neuraxial anaesthesia for caesarean section, aiming for a sensory block to the T5 level or above. A second testing modality is recommended in cases where there is doubt over the light touch assessment. In practice, many anaesthetists will consider anaesthesia to be adequate when block to light touch is demonstrated to the T5 level or above and cold to the T4 level or above.

Ethyl chloride spray is the most common piece of equipment for used for testing in the UK. It has been shown that ethyl chloride spray can be used for the assessment of light touch and is equivalent to established methods when assessing adequacy of the block for surgery. However, ethyl chloride has disadvantages: skin irritation and allergic reactions sometimes occur; and containers are expensive, require replacing and carry a carbon footprint. The spray also remains in the atmosphere for up to two months and this can have a deleterious effect on the environment.

Cotton wool has been shown to be as effective at testing light touch when compared to more expensive methods. However, it is not necessarily practical to have multiple pieces of equipment required to assess different block modalities. Given that ethyl chloride is commonly used to test both modalities, a more sustainable and cost-effective approach to testing both light touch and cold would be ideal.

Theophany Limited recently developed the CoolStick for assessment of block height to cold. The CoolStick consists of a stainless-steel head and a plastic handle. It is kept in the fridge before use and is cleaned with an antibacterial wipe between patients. The CoolStick maintains a temperature adequate for cold assessment for up to 10 minutes in ambient theatre temperature and should be kept refrigerated for at least 40 minutes prior to use. It appears to be a more sustainable and cost-effective alternative to ethyl chloride spray; however, there are no studies that demonstrate its clinical application in this setting.

The primary aim of this study is to compare Coolstick with ethyl chloride spray for the assessment of light touch, with the secondary aim of comparing CoolStick to ethyl chloride for the assessment of cold.

Conditions
Anesthesia
Being tested
CoolStick, Ethyl Chloride, Question

What participants receive

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

  • CoolStickOther

    Assessment of block using CoolStick.

  • Ethyl ChlorideOther

    Assessment of block using ethyl chloride spray

  • QuestionOther

    Participant will be asked if they felt pain or not.

Study groups in NCT06596486
Study groupRoleWhat they receive
All participantsAll participants will receive standard care with the addition of extra assessment of block from neuraxial anaesthesia
Receives: Other: CoolStick; Other: Ethyl Chloride; Other: Question

What is being measured

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

  1. Light Touch

    The dermatomal block level to light touch at 10 minutes after spinal injection measured using CoolStick and Ethyl Chloride spray.

    Measured: 6 months

Secondary outcomes (1)
  1. Cold

    The dermatomal block level to cold at 10 minutes after spinal injection measured using CoolStick and Ethyl Chloride spray.

    Measured: 6 months

Timeline

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

  1. First posted19 Sep 2024
  2. Study start1 Apr 2025
  3. Primary completion29 Jan 2026
  4. Study completion29 Jan 2026

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
Case only
Time perspective
Prospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06596486
Sponsor's protocol ID
331686
Status last verified
Feb 2026
First submitted
22 Aug 2024
Last updated
27 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Barts & The London NHS Trust at 3 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Light Touch (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in