Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia

NACompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Medical; Abortion, Fetus
Interventions
PROCEDURE

Programmed Intermittent Epidural Bolus

An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was \< 30 mm were administered.

PROCEDURE

Continuous Epidural Infusion

An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was \< 30 mm were administered.

PROCEDURE

Procedure of interruption of pregnancy

Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.

DRUG

Drug used for analgesia procedures

Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).

DEVICE

Pump for programmed intermittent bolus.

Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.

DEVICE

Pump for continuous epidural infusion.

Pump administering continuous epidural infusion for the maintenance of analgesia was used.

DRUG

Drug used for termination of pregnancy procedure.

Gemeprost pessaries.

Trial Locations (1)

16132

Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa, Genoa

All Listed Sponsors
lead

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

OTHER

NCT01860521 - Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia | Biotech Hunter | Biotech Hunter