Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT04716660
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study
Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Organization:
Study Overview
Official Title:
Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: