Assessment of Sensory Block During Labour Epidural Analgesia in Patients Experiencing Pain During First Stage of Labour.

NCT05881395 | Completed

• 1 other identifier: 23-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia is the gold standard for pain control during labour and an essential component of delivering effective and safe epidural analgesia is the assessment of the epidural sensory block. There is significant literature on the assessment of sensory block during spinal anesthesia for cesarean section but limited studies exploring the assessment of sensory blockade in labour analgesia. Prior studies have documented two thresholds of sensory block to both ice and pinprick: one defined as the lower sensory block level (LSBL) where the patient is able to notice a cold or sharp sensation but perceives that is not as sharp or cold as a control area and the other the upper sensory block level (USBL) where the patient perceives the cold or sharp sensation is at the same temperature or sharpness as the control area. The goal of this study is to contribute to the standardization of the assessment of sensory block levels during labour epidural analgesia by studying patients with labour epidurals who are experiencing pain and determining the LSBL and USBL and how these change as the patients become comfortable following the administration of manual epidural top ups.

Conditions

Labor Pain

Keywords

epidural analgesia; sensory block; programmed intermittent epidural bolus

Outcome Measures

Primary Outcomes (4)

• Lower sensory block level to ice when the patient is experiencing pain

  The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.

  5 minutes

• Upper sensory block level to ice when the patient is experiencing pain

  The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.

  5 minutes

• Lower sensory block level to pinprick when the patient is experiencing pain

  The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.

  5 minutes

• Upper sensory block level to pinprick when the patient is experiencing pain

  The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.

  5 minutes

Secondary Outcomes (11)

• Verbal Numeric Rating Score (VNRS) at the time of request of assessment by anesthesiologist

  5 minutes

• Verbal Numeric Rating Score (VNRS) at 10 minutes after each epidural top-up administered.

  10 minutes

• Lower sensory block level to ice following epidural top-up

  5 minutes

• Upper sensory block level to ice following epidural top-up

  5 minutes

• Lower sensory block level to pinprick following epidural top-up

  5 minutes

Study Arms (1)

Women with epidural analgesia experiencing pain during labor

Patients reporting pain will have their sensory block checked using ice and pinprick tests, prior to, and following and epidural top-up.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour and experience pain that is addressed by the anesthesiologist.

You may qualify if:

• ASA (American Society of Anesthesiologists) Physical Status Classification II or III
• Patients admitted to labour and delivery unit at Mount Sinai Hospital in their first stage of labour
• Patients who have a labour epidural that has been initiated as an epidural, CSE (combined spinal epidural) or a dural puncture epidural (DPE).
• Patients who are experiencing pain, defined as Visual Numerical Rating Score of more than 1/10, despite our institution's standard epidural Programmed Intermittent Epidural Bolus maintenance regimen and request a manual epidural top-up for the first time
• Have capacity to consent to the study

You may not qualify if:

• Patients with a language barrier that may interfere with accurate response to sensory block assessment
• Patients with medical conditions that would compromise sensitivity to cold or pinprick assessments
• patients who sustained unintentional dural puncture, those requiring change in our standard epidural maintenance regimen or those who have had a failed epidural requiring replacement.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Kordich L, Ghiringhelli JP, George RB, Downey K, Ye XY, Carvalho J. Characterizing patterns of sensory loss during labor epidural analgesia: a prospective study of breakthrough pain. Int J Obstet Anesth. 2025 Nov;64:104753. doi: 10.1016/j.ijoa.2025.104753. Epub 2025 Aug 12.

  PMID: 40876244 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose 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: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 16, 2023
• Primary Completion: December 2, 2023
• Study Completion: December 3, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)