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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716660
• Other study ID #: 21-01
• Status: Completed
• Start date: February 2, 2021
• Est. completion date: August 9, 2021

Study information

• Verified date: September 2021
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• Sensory block level check
Patients will have their sensory block level checked multiple times following administration of their epidural bolus for labor analgesia.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Motor block score using Bromage score	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.	20 to 160 minutes post-loading dose
Secondary	Pain score	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.	20 to 160 minutes post-loading dose
Secondary	Additional analgesia administered	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.	160 minutes