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Completed

NCT Number: NCT04716660

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request and have no contraindications to receive epidural analgesia
  • 18 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sensory block level check

Other

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

Primary outcomes

  1. Change in Lower sensory block level over time

    Time frame: 20 to 160 minutes post-loading dose

    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.

  2. Change in Upper sensory block level over time

    Time frame: 20 to 160 minutes post-loading dose

    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.

Secondary outcomes

  1. Motor block score using Bromage score

    Time frame: 20 to 160 minutes post-loading dose

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

  2. Pain score

    Time frame: 20 to 160 minutes post-loading dose

    Pain score using verbal numerical rating scale (VNRS) (0-10, where 0=no pain and 10=worst pain ever). This will be measured at 20, 60, 80, 90, 100, 110, 120, 130, 140, 150, and 160 minutes post-loading dose of epidural medication.

  3. Additional analgesia administered

    Time frame: 160 minutes

    Use and timing of use of PCEA and/or manual bolus will be recorded if they are administered at any time during the study time period.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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