drugset / Trial / NCT01858090

Intrathecal Levobupivacaine With Opioids for Caesarean Section

NCT01858090

Phase 3 Completed 93 enrolled Baskent University
RandomizedParallel-groupDouble-blindTreatment

Summary

In this prospective, randomized, double-blind, controlled study, the aim was to compare the effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml 0.5%) on the intraoperative anesthesia quality, block characteristics, the side effects on the newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction score.

Timeline

Start
2009-01
Primary completion
2009-10
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 10 ug Intrathecal
Comparator Levobupivacaine Other / unclassified 11 mg Intrathecal
Comparator Levobupivacaine Other / unclassified 12 mg Intrathecal
Comparator Sufentanil Other / unclassified 2.5 ug Intrathecal
Comparator Atropine Other / unclassified 0.5 mg
Comparator Diclofenac Other / unclassified 75 mg Intramuscular
Comparator Diphenhydramine Unknown 25 mg
Comparator Ephedrine Small molecule 5 mg
Comparator Meperidine Unknown 50 mg Intramuscular
Comparator Metoclopramide Small molecule 10 mg Intravenous
Comparator Propofol Small molecule 0.5 mg/kg Intravenous

Indications

No indication recorded.