Phase 2 N=45 Randomized Quadruple-blind Treatment

Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02430090 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 5; 10; 9 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Levobupivacaine (Drug); Fentanyl (Drug); Sufentanil (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Ankara City Hospital Bilkent
Primary completion: Mar 2007

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	—	—

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.

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.

View full record on ClinicalTrials.gov →

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.