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

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Diagnostic Test: Sensory block level check using ice

• Registration Number: NCT03572439
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-28
• Study Start: 2018-07-17
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cephalad to caudal	Sensory block level check using ice	Sensory block level check using ice, moving from cephalad to caudal
Caudal to cephalad	Sensory block level check using ice	Sensory block level check using ice, moving from caudal to cephalad

Primary Outcome Measures

Name	Time	Method
The upper sensory block level to cold	1 hour	The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
The lower sensory block level to cold	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	20 minutes	Patients 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 cold	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
The upper sensory block level to cold	2 hours	The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada