PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial
Condition: Labor Epidural Analgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators have design a randomized double blind clinical trial to know the incidence
      of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical
      dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses
      versus patient controlled epidural analgesia. The role of the epidural technique (epidural
      versus combined spinal-epidural) in the incidence of BP will be also evaluated.
    

Detailed description: 
      Women in labor receiving epidural analgesia may experience breakthrough pain (BP) that
      requires the use of additional medication and that is a source of dissatisfaction with the
      analgesic treatment for labor.

      The investigators can define two types of BP: 'primary breakthrough pain' is the first moment
      when the patient requests analgesia during labor. 'Secondary breakthrough pain' can be
      defined as the time a previously effective epidural analgesia turns ineffective.

      The BP may have multiple causes, such as delivery progression and catheter misplacement.
      There is no single pattern to provide adequate neuraxial analgesia for labor, but for certain
      patients and specific clinical situations some methods provide advantages over others.

      The choice of a suitable system of epidural drug delivery has an important role in getting
      proper analgesia and a low incidence of breakthrough pain during labor. In order to develop
      preventive strategies for BP, some clinical scales to estimate its incidence rate have been
      described. Among risk factors for BP the investigators can include: Nulliparity, epidural
      catheter placement at an earlier cervical dilation, neonatal weight and technique performed
      (epidural versus combined spinal-epidural - CSE).

      In addition, technological development has offered us new treatment modalities of pain
      management during childbirth have evolved recently to improve maternal satisfaction, as well
      as to treat and prevent BP: Patient Controlled Epidural Analgesia (PCEA) added or not to a
      continuous epidural infusion (CEI), computer integrated PCEA (CI-PCEA) and automatic or
      programed intermittent epidural boluses (PIEB).

      Nowadays, there is no evidence about the best epidural analgesic treatment or the optimum
      epidural punction in order to reduce BP episodes and, hence, increase maternal satisfaction.

      Therefore, the investigators have design a randomized double blind clinical trial to know the
      incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early
      cervical dilation) comparing two epidural analgesic regimes added to a contiuous infusion of
      L-bupivacaine plus fentanyl: programed intermittent epidural boluses versus patient
      controlled epidural analgesia. The role of the epidural technique (epidural versus combined
      spinal-epidural) in the incidence of BP will be also evaluated.
    

Intervention name(s): PCEA vs PIEB; Epidural vs CSE
Intervention type(s): Device; Procedure
Intervention description(s): We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor; We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment