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CompletedNCT05187962Updated Oct 25, 2022

Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch

An observational study in Labor Pain, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.

02

Conditions studied

  • Labor Pain

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Keywords

  • sensory block
  • epidural analgesia
  • programmed intermittent epidural bolus
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In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 30 is below the median of 101 across 56 observational studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour.

Inclusion criteria

  • ASA Physical Status Classification II and III parturients
  • Requested and received a labour epidural
  • Capable of consenting to the study
  • Have no language barrier which may obfuscate the sensory block assessment
  • Are receiving programmed intermittent epidural boluses (PIEB) for maintenance analgesia, which is the Mount Sinai Hospital default maintenance regimen

Exclusion criteria

Exclusion Criteria:

  • Medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch
  • Epidurals performed under a combined spinal-epidural (CSE) or dural puncture epidural (DPE) technique
  • Epidurals with a documented unintentional dural puncture
  • Inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Women receiving epidural analgesia for labor

    Sensory block level check Patients will have their sensory block level checked using 3 modalities: ice, pin prick and soft touch (cotton ball).

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What researchers measure

Primary outcomes

  1. Lower sensory block level: ice test

    The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception.

    Time frame: 5 minutes

  2. Upper sensory block level: ice test

    The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.

    Time frame: 5 minutes

  3. Lower sensory block level: pinprick test

    The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation.

    Time frame: 5 minutes

  4. Upper sensory block level: pinprick test

    The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss.

    Time frame: 5 minutes

  5. Sensory block level: soft touch test

    The sensory block level using soft touch is defined as the dermatome below which the patient can feel a light touch.

    Time frame: 5 minutes

Secondary outcomes

  1. Motor block score using Bromage score

    Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.

    Time frame: 5 minutes

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Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05187962
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible party
Sponsor
First posted
Jan 12, 2022
Start date
Dec 21, 2021
Primary completion
Jul 27, 2022
Completion
Jul 27, 2022
Last update
Oct 25, 2022

Study contacts

Jose CA Carvalho, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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