Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor-3
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

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).
    

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 vary the volume of the bolus (7-12 mL) of bupivacaine
      0.0625% with fentanyl 2mcg/ml. PCEA bolus of 5mL of the same solution will also be available.
      The goal is to establish the ideal PIEB volume that will be effective for our patient
      population.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): 0.0625% Bupivacaine plus fentanyl 2mcg/ml
Other intervention name(s): Marcaine
Intervention MeSH terms: 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