Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Until recently, at Mount Sinai Hospital, 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, intermittent programmed pushes should be used. 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). The new
      pumps are able 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 can prolong the duration of analgesia, diminish motor block, lower the incidence
      of breakthrough pain, improve maternal satisfaction and decrease local anesthetic
      consumption. Based on the information already available in the literature, this study aims to
      determine the best regimen of PIEB achievable with our standard epidural mixture.

      The hypothesis of this study is that there is an optimal interval time between PIEB boluses
      of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will
      provide women the necessary drug requirements, thus avoiding breakthrough pain and need for
      PCEA or physician intervention.
    

Detailed description: 
      All studies involving PIEB to date have provided an analgesic regimen that delivered an
      amount of local anesthetic that was below the patient's requirement per hour, as the studies
      were done in the context of an association with PCEA (Patient controlled epidural anesthesia)
      as a rescue technique. As a result, PCEA requests were frequent and therefore these studies
      have not been able to truly understand the pharmacology of the bolus technique in the PIEB
      regimen, as the PCEA utilized by patients added an extra component to the regimen.

      The ideal volume and interval time between PIEB bolus has not yet been established in the
      literature. Most likely the ideal volume and interval time between PIEB bolus will be
      specific for each epidural mixture.

      At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard
      epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Our current epidural regimen
      consists of 10 ml continuous infusion per hour, with PCEA boluses of 5 ml and a lock out
      interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour. In this
      study, the investigators will offer patients 10mL PIEBs of bupivacaine 0.0625% with fentanyl
      2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be
      available. The goal is to establish the ideal PIEB regimen that will be effective for our
      patient population with our standard epidural mixture.

      Finding the best way of using the new device that will be able to provide analgesia for 90%
      of the parturients will represent a great improvement in labor analgesia. Moreover, there are
      expectations of having fewer side effects since the PIEB is more effective than CEI.
    

Intervention name(s): Bupivacaine; Fentanyl; Infusion pump
Intervention type(s): Drug; Drug; Device
Intervention description(s): 0.0625% Bupivacaine plus fentanyl 2mcg/ml; 0.0625% Bupivacaine plus fentanyl 2mcg/ml; Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
Other intervention name(s): Marcaine; CADD-Solis Ambulatory Infusion Pump
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural; Labor analgesia; Programmed intermittent epidural bolus