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 (Other)
• Overall Status: Completed
• CT.gov ID: NCT04716660
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Other: Sensory block level check

Study Design

• Study Type: Observational
• Actual Enrollment: 34 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study
• Actual Study Start Date: Feb 2, 2021
• Actual Primary Completion Date: Aug 9, 2021
• Actual Study Completion Date: Aug 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Women receiving epidural analgesia for labor	Other: Sensory block level check; Patients will have their sensory block level checked multiple times following administration of their epidural bolus for labor analgesia.

Outcome Measures

Primary Outcome Measures

1. Change in Lower sensory block level over time [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 [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 Outcome Measures

1. Motor block score using Bromage score [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G1X5

Sponsors and Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

• Principal Investigator: Jose CA Carvalho, MD, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• ClinicalTrials.gov Identifier: NCT04716660
• Other Study ID Numbers: 21-01
• First Posted: Jan 20, 2021
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital: programmed intermittent epidural bolus; epidural analgesia; labor epidural; sensory block
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Sep 21, 2021