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Completed

NCT Number: NCT03572439

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

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).

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory block level check using ice

Diagnostic Test

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

Primary outcomes

  1. The lower sensory block level to cold

    Time frame: 1 hour

    The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold

  2. The upper sensory block level to cold

    Time frame: 1 hour

    The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

Secondary outcomes

  1. Patient satisfaction

    Time frame: 20 minutes

    Patients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable

  2. The lower sensory block level to cold

    Time frame: 2 hours

    The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold

  3. The upper sensory block level to cold

    Time frame: 2 hours

    The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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