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

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

Status: Completed

Conditions: Medical; Abortion, Fetus

Treatments: Procedure: Continuous Epidural Infusion; Device: Pump for programmed intermittent bolus.; Drug: Drug used for termination of pregnancy procedure.; Drug: Drug used for analgesia procedures; Device: Pump for continuous epidural infusion.; Procedure: Procedure of interruption of pregnancy; Procedure: Programmed Intermittent Epidural Bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT01860521

SCUL 4022

Details and patient eligibility

About

This study included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.

Enrollment: 104 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years
• pregnancy at second trimester
• willingness of voluntary interrupt the pregnancy
• comprehension of Italian Language
• baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)

Exclusion criteria

• contraindication to epidural analgesia and to narcotics
• history of drug abuse or chronic use
• maternal disease (such as severe asthma, cardiac, liver or kidney disease)
• inability to comprehend or comply with the analgesia pain management procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Programmed Intermittent Epidural Bolus

Active Comparator group

Treatment:

Procedure: Procedure of interruption of pregnancy

Drug: Drug used for analgesia procedures

Drug: Drug used for termination of pregnancy procedure.

Device: Pump for programmed intermittent bolus.

Procedure: Programmed Intermittent Epidural Bolus

Continuous Epidural Infusion

Active Comparator group

Treatment:

Procedure: Continuous Epidural Infusion

Procedure: Procedure of interruption of pregnancy

Device: Pump for continuous epidural infusion.

Drug: Drug used for analgesia procedures

Drug: Drug used for termination of pregnancy procedure.