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

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187962
• Other study ID #: 21-08
• Status: Completed
• Start date: December 21, 2021
• Est. completion date: July 27, 2022

Study information

• Verified date: October 2022
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Secondary	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.	5 minutes