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

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)

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).

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Diagnostic test: Sensory block level check using ice

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cephalad to caudal; Sensory block level check using ice, moving from cephalad to caudal	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.
Active Comparator: Caudal to cephalad; Sensory block level check using ice, moving from caudal to cephalad	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: epidural; sensory block level; dermatome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 18-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No