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

NCT05187962 | Completed

• 1 other identifier: 21-08
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

sensory block; epidural analgesia; programmed intermittent epidural bolus

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Motor block score using Bromage score

  5 minutes

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 38291174 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 12, 2022
• Study Start: December 21, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)