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COMPARATION BETWEEN TWO SCHEMES OF ANALGESIA IN PREGNANT WOMEN

Breakthrough pain incidence in pregnant women comparing two Epidural analgesia shemes added to a continuous infusion (bowling planned indicators and analgesia epidural patient controlled): double-blind randomized

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004696-24-ES
Enrollment
Unknown
Registered
2015-08-25
Start date
2016-02-29
Completion date
Unknown
Last updated
2016-04-25

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

Conditions

EPIDURAL ANALGESIA IN PARTURIENTS

Interventions

Trade Name: Levobupivacaine Product Name: LEVOBUPIVACAINE Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LEVOBUPIVACAINE CAS Number: 27262-47-1 Concentration unit: ml millil

Sponsors

HOSPITAL UNIVERSITARIO LA PAZ, SERVICIO DE ANESTESIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Parturient women who demand labor epidural analgesia ? Age between 18 and 40 years. ? Primiparous. ? Working spontaneous or induced labor. ? Informed consent duly completed. ? Neck dilation less than 4 cm cervical. ? Gestational age between 37 and 41 weeks of amenorrhea Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Contraindications for epidural anesthesia. ? Labor induced ? Lack of consent or understanding study failures

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate the incidence of breakthrough pain in pregnant women who received epidural analgesia along dilation under two different analgesic regimens;Secondary Objective: Measure the total consumption of local anesthetic during expansion To study the incidence of technical failure of the epidural and CSE Analysis of the type of delivery (spontaneous, instrumental and caesarean section) in our patients;Primary end point(s): 50% decrease in the rate of breakthrough pain treated with bolus PIEB treated without regard to bowling PIEB group. This is to establish the total number of episodes of breakthrough pain in both groups throughout the period of labor.;Timepoint(s) of evaluation of this end point: NOT APPLICABLE—

Secondary

MeasureTime frame
Secondary end point(s): NOT APPLICABLE;Timepoint(s) of evaluation of this end point: At different times (baseline, each visit, end of treatment)—

Countries

Spain

Contacts

Public ContactSERVICIO DE ANESTESIA

HOSPITAL UNIVERSITARIO LA PAZ

HOI.TONG@IDIPAZ.ES34917277558

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026