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.
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
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 group | Role | What they receive |
|---|---|---|
| All participants | All 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.
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)
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.
- First posted19 Sep 2024
- Study start1 Apr 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Wikner, Study chair, Barts & The London NHS Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06596486
- Acronym / sponsor ID
- 331686
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: CoolStick, Other: Ethyl Chloride, Other: QuestionAll participants will receive standard care with the addition of extra assessment of block from neuraxial anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All eligible patients presenting for elective caesarean section will be invited to participate in the study.
Key inclusion criteria (1 listed)
- Pregnant patients presenting for elective caesarean section under spinal or combined spinal-epidural anaesthesia.
Key exclusion criteria (5 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolStickAssessment of block using CoolStick. | Other | All participants |
| Ethyl ChlorideAssessment of block using ethyl chloride spray | Other | All participants |
| QuestionParticipant will be asked if they felt pain or not. | Other | All participants |
Primary outcome
Light Touch
Time frame: 6 months
The dermatomal block level to light touch at 10 minutes after spinal injection measured using CoolStick and Ethyl Chloride spray.
1 secondary outcome
Cold
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Wikner study chair
Barts & The London NHS Trust
3 sites in 1 country: see every site and its status.
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.