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

NCT ID: NCT04716660

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2021-08-09

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women receiving epidural analgesia for labor

Sensory block level check

Intervention Type: OTHER

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

Interventions

Sensory block level check

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36076123 (View on PubMed)

Other Identifiers

21-01

Identifier Type: -

Identifier Source: org_study_id