Back to resultsIdentification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sensory block level check using ice
Sponsored by
About this trial
This is an interventional prevention trial for Labor Pain focused on measuring epidural, sensory block level, dermatome
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cephalad to caudal
Caudal to cephalad
Arm Description
Sensory block level check using ice, moving from cephalad to caudal
Sensory block level check using ice, moving from caudal to cephalad
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Patient satisfaction
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
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
The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
Full Information
NCT ID
NCT03572439
First Posted
June 18, 2018
Last Updated
February 21, 2019
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03572439
Brief 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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
epidural, sensory block level, dermatome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cephalad to caudal
Arm Type
Active Comparator
Arm Description
Sensory block level check using ice, moving from cephalad to caudal
Arm Title
Caudal to cephalad
Arm Type
Active Comparator
Arm Description
Sensory block level check using ice, moving from caudal to cephalad
Intervention Type
Diagnostic Test
Intervention Name(s)
Sensory block level check using ice
Intervention Description
Patients are asked to report when the ice feels as cold as it does on the forehead.
Primary Outcome Measure Information:
Title
The lower sensory block level to cold
Description
The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
Time Frame
1 hour
Title
The upper sensory block level to cold
Description
The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable
Time Frame
20 minutes
Title
The lower sensory block level to cold
Description
The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
Time Frame
2 hours
Title
The upper sensory block level to cold
Description
The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
Time Frame
2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35289377
Citation
de Souza Soares EC, Balki M, Downey K, Ye XY, Carvalho JCA. Assessment of sensory block during labour epidural analgesia: a prospective cohort study to determine the influence of the direction of testing. Can J Anaesth. 2022 Jun;69(6):750-755. doi: 10.1007/s12630-022-02228-x. Epub 2022 Mar 14.
Results Reference
derived
Learn more about this trial
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
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