Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil|
- Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
- Motor blockade quantification by a score of modified Bromage specific way.
- Labor analgesia.
- Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).
|Study Start Date:||February 2007|
|Study Completion Date:||January 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437996
|Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse|
|Lyon, France, 69004|
|Henri Jacques CLEMENT|
|Lyon, France, 69000|
|Principal Investigator:||HENRI-JACQUES CLEMENT, MD||Hospices Civils de Lyon|