MedTrace Logo

Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow

NCT03236298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-03-20

No results posted yet for this study

Summary

At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown that delivering analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption comparing to a conventional continuous infusion. The use of this PIEB technique in routine practice has reduced the total consumption of local anesthetic and the percentage of patients requesting additional boluses (PCEA or manual rescues).

However, at the same time, sensory blocks above those targeted for labor pain relief have been reported in our institution, suggesting that the spread of the freezing medication is wider than necessary. Based on the information already available in the literature, the investigators will conduct this study to determine the best regimen of PIEB achievable with a slower delivery speed.

The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the incidence of women presenting sensory block to ice equal or higher than T6 as compared to a delivery rate of 250 mL/h.

Conditions

  • Labor Pain

Interventions

DEVICE

CADD-Solis Ambulatory Infusion System

The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose CA Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-01-22
Completion
2020-01-23

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03236298 on ClinicalTrials.gov