PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial (PIEB-CT)

M

Madrid Health Service

Status and phase

Completed
Phase 4

Conditions

Labor Epidural Analgesia

Treatments

Device: PCEA vs PIEB
Procedure: Epidural vs CSE

Study type

Interventional

Funder types

Other

Identifiers

NCT02768272
2014-004696-24

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 40 years
  • Gestational age between 37 and 41 weeks
  • Singleton pregnancies
  • Nulliparity
  • Spontaneous or induced labor
  • Cervical dilation less than four centimeters

Exclusion criteria

  • Do not meet all the inclusion criteria
  • Do not consent to the study
  • Systemic medical pathologies as pre-eclampsia, insulin-treated gestational diabetes or multiple sclerosis that could influence medical decision during labour and/or make randomization unfeasible
  • Contraindication for neuraxial analgesia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups

Epidural analgesia
Experimental group
Description:
Randomized allocation to receive patient controlled epidural analgesia or programed intermittent epidural boluses
Treatment:
Device: PCEA vs PIEB
Epidural technique
Experimental group
Description:
Randomized allocation to be punctioned a conventional epidural or a combined spinal-epidural technique
Treatment:
Procedure: Epidural vs CSE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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