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Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing

Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing (Anesthetized Area to Non-anesthetized Area Versus Non-anesthetized to Anesthetized Area)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572439
Enrollment
30
Registered
2018-06-28
Start date
2018-07-17
Completion date
2019-01-10
Last updated
2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

epidural, sensory block level, dermatome

Brief summary

Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. A variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. In addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. Not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. Another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. This lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. Considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. The objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).

Interventions

DIAGNOSTIC_TESTSensory block level check using ice

Patients are asked to report when the ice feels as cold as it does on the forehead.

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* patients who request and have no contraindications to receive epidural analgesia * capable of understanding and signing the written informed consent * have no language barrier to respond to the level of sensory block assessment * have no conditions that could compromise their sensitivity to cold.

Exclusion criteria

* patients who refuse to sign consent * epidural analgesia is contraindicated

Design outcomes

Primary

MeasureTime frameDescription
The lower sensory block level to cold1 hourThe sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
The upper sensory block level to cold1 hourThe sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

Secondary

MeasureTime frameDescription
Patient satisfaction20 minutesPatients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable
The lower sensory block level to cold2 hoursThe sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
The upper sensory block level to cold2 hoursThe sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026