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

NCT ID: NCT05187962

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-21

Study Completion Date

2022-07-27

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Casellato JF, Balki M, Wang A, Ye XY, Downey K, Carvalho JCA. Differential sensory block during labour epidural analgesia: a prospective observational study to investigate the relationship of lower and upper sensory block levels to cold, pinprick, and light touch. Can J Anaesth. 2024 Jun;71(6):802-807. doi: 10.1007/s12630-023-02638-5. Epub 2024 Jan 30.

Reference Type DERIVED
PMID: 38291174 (View on PubMed)

Other Identifiers

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21-08

Identifier Type: -

Identifier Source: org_study_id

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