NCT06596486

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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 22, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

August 22, 2024

Last Update Submit

February 26, 2026

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Light Touch

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

    6 months

Secondary Outcomes (1)

  • Cold

    6 months

Other Outcomes (1)

  • Intraoperative pain

    6 months

Study Arms (1)

All participants

All participants will receive standard care with the addition of extra assessment of block from neuraxial anaesthesia

Other: CoolStickOther: Ethyl ChlorideOther: Question

Interventions

CoolStickOTHER

Assessment of block using CoolStick.

All participants
Ethyl ChlorideOTHER

Assessment of block using ethyl chloride spray

All participants
QuestionOTHER

Participant will be asked if they felt pain or not.

All participants

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Newham University Hospital

London, United Kingdom

Location

The Royal London Hospital

London, United Kingdom

Location

Whipps Cross University Hospital

London, United Kingdom

Location

MeSH Terms

Interventions

Ethyl Chloride

Intervention Hierarchy (Ancestors)

Hydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsOrganic Chemicals

Study Officials

  • Matthew Wikner

    Barts & The London NHS Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2024

First Posted

September 19, 2024

Study Start

April 1, 2025

Primary Completion

January 29, 2026

Study Completion

January 29, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)