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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor-3

NCT02887222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-25

No results posted yet for this study

Summary

Until recently, at Mount Sinai Hospital (MSH), epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion we should use intermittent programmed pushes. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). Recently the epidural pumps at MSH were reprogrammed to deliver bolus of medication at regular intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. The investigators have recently concluded a study at MSH using PIEB where excellent results were observed. However, in that study, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same interval of the previous study with smaller volumes of the intermittent boluses. Optimizing the technique, may allow the investigators to be able to reduce even further the amount of medication used by each patient.

The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of women the necessary drug requirements during first stage of labor (EV90), thus avoiding breakthrough pain and need for PCEA or physician intervention. We hypothesize that this effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).

Conditions

  • Labor Pain

Interventions

DRUG

Bupivacaine

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
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

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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 NCT02887222 on ClinicalTrials.gov