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PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial

A Randomized Double Blind Clinical Trial Comparing Programed Intermittent Epidural Boluses (PIEB) Versus Patient Controlled Epidural Analgesia (PCEA) With Epidural or Combined Spinal-epidural (CSE) Technique

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02768272
Acronym
PIEB-CT
Enrollment
240
Registered
2016-05-11
Start date
2016-03-01
Completion date
2017-08-31
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Epidural Analgesia

Brief 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.

Interventions

DEVICEPCEA vs PIEB

We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor

PROCEDUREEpidural vs CSE

We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor

Sponsors

Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18 and 40 years 2. Gestational age between 37 and 41 weeks 3. Singleton pregnancies 4. Nulliparity 5. Spontaneous or induced labor 6. Cervical dilation less than four centimeters

Exclusion criteria

1. Do not meet all the inclusion criteria 2. Do not consent to the study 3. 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 4. Contraindication for neuraxial analgesia

Design outcomes

Primary

MeasureTime frameDescription
Incidence of breakthrough painLaborEvaluation of breakthough pain episodes since epidural punction to delivery

Secondary

MeasureTime frameDescription
Total epidural infusion volumeLaborMeasurement of the total epidural infusion volume administered to the patient
Incidence of epidural failureLaborAssesment the incidence of failed epdirual technique
Mode of delivery (spontaneous, intrumental and cesarean section)DeliveryAnalysis of the potential relation of the interventions with the type of delivery

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026