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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2019-01-10

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).

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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cephalad to caudal

Sensory block level check using ice, moving from cephalad to caudal

Group Type ACTIVE_COMPARATOR

Sensory block level check using ice

Intervention Type DIAGNOSTIC_TEST

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

Caudal to cephalad

Sensory block level check using ice, moving from caudal to cephalad

Group Type ACTIVE_COMPARATOR

Sensory block level check using ice

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Sensory block level check using ice

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

Intervention Type DIAGNOSTIC_TEST

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.