N/A
Completed N=104
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
Medical; Abortion, Fetus
Source: ClinicalTrials.gov NCT01860521 ↗
Enrolled (actual)
104
Serious AEs
5.8%
Results posted
Oct 2013
Primary outcomePrimary: Incidence of Motor Block — 24; 3 participants — p=< 0.001
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.
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 |
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.
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. Informational only — not medical advice.