Clinical trial NCT05187962: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: sensory block
epidural analgesia
programmed intermittent epidural bolus
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Lower sensory block level: ice test
timeFrame: 5 minutes
measure: Upper sensory block level: ice test
timeFrame: 5 minutes
measure: Lower sensory block level: pinprick test
timeFrame: 5 minutes
measure: Upper sensory block level: pinprick test
timeFrame: 5 minutes
measure: Sensory block level: soft touch test
timeFrame: 5 minutes
Secondary outcomes:
measure: Motor block score using Bromage score
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: