N/A N=104 Randomized Quadruple-blind Treatment

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

Medical; Abortion, Fetus

Bottom Line

View on ClinicalTrials.gov: NCT01860521 ↗

Enrolled (actual)

104

Serious AEs

5.8%

Results posted

Oct 2013

Primary outcome: Primary: Incidence of Motor Block — 24; 3 participants — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Programmed Intermittent Epidural Bolus (Procedure); Continuous Epidural Infusion (Procedure); Procedure of interruption of pregnancy (Procedure); Drug used for analgesia procedures (Drug); Pump for programmed intermittent bolus. (Device); Pump for continuous epidural infusion. (Device); Drug used for termination of pregnancy procedure. (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Motor Block	24; 3	< 0.001 sig
SECONDARY Degree of Satisfaction of the Patients With the Analgesia Procedure	73.2; 84.4	0.005 sig
SECONDARY Total Levobupivacaine Consumption	86.2; 75.5	0.047 sig
SECONDARY Total Sufentanil Consumption.	69.0; 60.4	0.047 sig

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01860521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.