Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study

NCT04716660 | Completed

• 1 other identifier: 21-01
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia is widely used for managing pain during labor. The programmed intermittent epidural bolus (PIEB) technique has been shown to produce less consumption of local anesthetics, better sensory block, less motor block, and increased maternal satisfaction than other epidural analgesia techniques. Despite all benefits from PIEB, such practice has been associated with high sensory block levels. Therefore, assessment of the sensory block level is an essential component of clinical safety. The lack of a standardized technique and timing to assess the sensory block level can lead to inappropriate management. The purpose of this study is to investigate the changes in block level over time, during cycles of a PIEB regimen. The investigators hypothesize that these levels will be highest soon after the PIEB bolus and lowest preceding the subsequent PIEB bolus. The investigators also want to investigate a possible correlation between these changes in sensory block levels and motor block, pain scores, and rescue bolus of local anesthetics.

Conditions

Labor Pain

Keywords

programmed intermittent epidural bolus; epidural analgesia; labor epidural; sensory block

Outcome Measures

Primary Outcomes (2)

• Change in Lower sensory block level over time

  The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be measured at 20, 60, 80, 90, 100, 110, 120, 130, 140, 150, and 160 minutes post-loading dose of epidural medication.

  20 to 160 minutes post-loading dose

• Change in Upper sensory block level over time

  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 measured at 20, 60, 80, 90, 100, 110, 120, 130, 140, 150, and 160 minutes post-loading dose of epidural medication.

  20 to 160 minutes post-loading dose

Secondary Outcomes (3)

• Motor block score using Bromage score

  20 to 160 minutes post-loading dose

• Pain score

  20 to 160 minutes post-loading dose

• Additional analgesia administered

  160 minutes

Study Arms (1)

Women receiving epidural analgesia for labor

Other: Sensory block level check

Interventions

Sensory block level check OTHER

Patients will have their sensory block level checked multiple times following administration of their epidural bolus for labor analgesia.

Women receiving epidural analgesia for labor

Eligibility Criteria

• Age: 18 Years - 55 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 request to receive epidural analgesia.

You may qualify if:

• women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request and have no contraindications to receive epidural analgesia
• years old or more
• capable of understanding and signing the written informed consent
• have no language barrier to respond to the level of sensory block assessment
• and have no conditions that could compromise the body sensitivity to cold.

You may not qualify if:

• unintentional dural puncture during labour epidural placement
• do not achieve adequate pain control 20 minutes after the loading dose (numeric rating scale (NRS)\>1 on a 0-10 NRS),
• deliver before 160 minutes following the loading dose
• require rescue boluses in the first 80 minutes after initiation of PIEB (that is, before the 2nd PIEB bolus)
• withdraw their consent.

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, Ye XY, Downey K, Carvalho JCA. Changes in sensory block level during a programmed intermittent epidural bolus regimen for labour analgesia: a prospective observational cohort study. Can J Anaesth. 2022 Dec;69(12):1471-1476. doi: 10.1007/s12630-022-02318-w. Epub 2022 Sep 8.

  PMID: 36076123 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: January 12, 2021
• First Posted: January 20, 2021
• Study Start: February 2, 2021
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)