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

Labor Pain Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572439
• Other study ID #: 18-05
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: February 2019
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Diagnostic Test:
• Sensory block level check using ice
Patients are asked to report when the ice feels as cold as it does on the forehead.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient satisfaction	Patients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable	20 minutes
Secondary	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
Secondary	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