Best mode of Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia.

Programmed Intermittent Epidural Bolus versus Continuous Epidural Infusion for third trimester voluntary termination of pregnancy analgesia : a randomized study. - PCEA-IMG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001738-33-FR

Enrollment

Registered

2015-08-05

Start date

2015-09-24

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Termination Pregancy MedDRA version: 18.0 Level: PT Classification code 10015011 Term: Epidural anaesthesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Chirocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: Levobupivacaine CAS Number: 27262-47-1 Other descriptive name: BUPIVACAINE HYDROCHLORIDE MONOHYDRATE Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age = 18 year -ASA 1 or 2 (healthy women) -pregnancy at third trimester -willingness of voluntary interrupt the pregnancy -women affiliated to french health social system -written informed consent from every patient 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 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -contraindications to epidural analgesia -opioids consumption within the last 24 hours -patient’s unwillingness -inability to comprehend or comply with the procedure

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate the benefit PIEB mode compared with the standard mode CEI in the Voluntary termination of pregancy after 22 weeks in terms of satisfaction with analgesia.;Secondary Objective: 1. A comparison of the number of calls to the anesthetist inadequate analgesia. 2. Comparison of doses of additional boli manually injected by the anesthetist (boli "rescue"). 3. Comparison of the total dose administered agents (as the PCEA pump at the end of the proceedings by a nurse). 4. Comparison of obstetric data: procedure time, prostaglandins and oxytocin doses administered, need for instrumental delivery. 5. The impact of the engine block and its intensity according to the modified Bromage score. 6. Comparison of the incidence of adverse effects of interest.;Primary end point(s): The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to « completely unsatisfied » and 100 to « completely satisfied ».;Timepoint(s) of evaluation of this end point: 24H	—

Measure

Time frame

Main Objective: Demonstrate the benefit PIEB mode compared with the standard mode CEI in the Voluntary termination of pregancy after 22 weeks in terms of satisfaction with analgesia.;Secondary Objective: 1. A comparison of the number of calls to the anesthetist inadequate analgesia. 2. Comparison of doses of additional boli manually injected by the anesthetist (boli "rescue"). 3. Comparison of the total dose administered agents (as the PCEA pump at the end of the proceedings by a nurse). 4. Comparison of obstetric data: procedure time, prostaglandins and oxytocin doses administered, need for instrumental delivery. 5. The impact of the engine block and its intensity according to the modified Bromage score. 6. Comparison of the incidence of adverse effects of interest.;Primary end point(s): The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to « completely unsatisfied » and 100 to « completely satisfied ».;Timepoint(s) of evaluation of this end point: 24H

—

Secondary

Measure	Time frame
Secondary end point(s): -Incidence of motor block. -Number of call of the aneshetist for insufficient analgesia -Doses of complementary manual bolus administered -Obstetrical informations : time of the intervention, doses of oxytocin and prostin used, instrumental delivery) -Adverse events ;Timepoint(s) of evaluation of this end point: 24H	—

Countries

France

Contacts

Public ContactDirector Recherche and Innovation

CHU de LIMOGES

drc@chu-limoges.fr+33555056349

Outcome results

None listed

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