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

Study Overview
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Brief Summary
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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).

Official Title
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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 (Anesthetized Area to Non-anesthetized Area Versus Non-anesthetized to Anesthetized Area)

Conditions
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Labor Pain

Intervention / Treatment
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* Diagnostic Test: Sensory block level check using ice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cephalad to caudal<br>Sensory block level check using ice, moving from cephalad to caudal | Diagnostic Test: Sensory block level check using ice<br>* Patients are asked to report when the ice feels as cold as it does on the forehead.<br>|
| Active Comparator: Caudal to cephalad<br>Sensory block level check using ice, moving from caudal to cephalad | Diagnostic Test: Sensory block level check using ice<br>* Patients are asked to report when the ice feels as cold as it does on the forehead.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lower sensory block level to cold | The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold | 1 hour | 
| The upper sensory block level to cold | The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable | 20 minutes | 
| The lower sensory block level to cold | The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold | 2 hours | 
| The upper sensory block level to cold | The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, sensory block level, dermatome