Phase 2
Completed N=45
Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Anesthesia
Source: ClinicalTrials.gov NCT02430090 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 5; 10; 9 participants
Summary
45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
5; 10; 9 | — |
| SECONDARY Number of Participants With Pain Scores on the Visual Analog Scale |
— | — |
Eligibility Criteria
Inclusion Criteria
- pregnant women with a single live fetus aged 18-45 years old and classified as ASA I, undergoing elective cesarean section, were included the study in november 2006 to march 2007
Exclusion Criteria
- Multiple pregnancies,
- preterm labor,
- eclampsia,
- preeclampsia,
- concomitant diabetes mellitus,
- allergy to local anesthetics, fentanyl or sufentanil,
- contraindication for regional anesthesia were the exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02430090). 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.