Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Brief 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
      investigators are currently using pumps set up with 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 they observed excellent results.
      However, some patients exhibited higher than necessary sensory blocks. The investigators
      believe that the technique can be optimized by using the same dose of the freezing
      medication, but using a smaller volume of local anesthetic at a higher concentration. This
      optimization may also further reduce the amount of medication used by each patient.

      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 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml
      that will provide women the necessary drug requirements, thus avoiding breakthrough pain and
      need for PCEA or physician intervention.
    

Detailed description: 
      Studies involving programmed intermittent epidural bolus (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 patient
      controlled epidural anesthesia (PCEA) 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.

      At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard
      epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Based on previous research
      done by the investigators, the current epidural regimen consists of 10 ml PIEB at 40 minute
      intervals, 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 5mL PIEBs of bupivacaine 0.125% 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 using a higher concentration epidural mixture.
    

Intervention name(s): Bupivacaine; Fentanyl; Infusion pump
Intervention type(s): Drug; Drug; Device
Intervention description(s): 0.125% Bupivacaine plus fentanyl 2mcg/ml; 0.125% 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural; Labor analgesia; Programmed intermittent epidural bolus