NCT03572439

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

June 18, 2018

Last Update Submit

February 21, 2019

Conditions

Labor Pain

Keywords

epiduralsensory block leveldermatome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Patient satisfaction

    20 minutes

  • The lower sensory block level to cold

    2 hours

  • The upper sensory block level to cold

    2 hours

Study Arms (2)

Cephalad to caudal

ACTIVE COMPARATOR

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

Diagnostic Test: Sensory block level check using ice

Caudal to cephalad

ACTIVE COMPARATOR

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

Diagnostic Test: Sensory block level check using ice

Interventions

Sensory block level check using iceDIAGNOSTIC_TEST

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

Caudal to cephaladCephalad to caudal

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • patients who refuse to sign consent
  • epidural analgesia is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35289377DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

July 17, 2018

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)