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Clinical Trials/NCT05187962
NCT05187962
Completed
Not Applicable

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 site in 1 country30 target enrollmentDecember 21, 2021
ConditionsLabor Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Enrollment
30
Locations
1
Primary Endpoint
Upper sensory block level: pinprick test
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 21, 2021
End Date
July 27, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Upper sensory block level: pinprick test

Time Frame: 5 minutes

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

Lower sensory block level: ice test

Time Frame: 5 minutes

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

Lower sensory block level: pinprick test

Time Frame: 5 minutes

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

Sensory block level: soft touch test

Time Frame: 5 minutes

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

Upper sensory block level: ice test

Time Frame: 5 minutes

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

Secondary Outcomes

  • Motor block score using Bromage score(5 minutes)

Study Sites (1)

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