Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial

Phase 3 Completed 85 enrolled Hospices Civils de Lyon

RandomizedParallel-groupDouble-blindPrevention

Summary

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.

Timeline

Start: 2007-02
Primary completion: —
Completion: 2008-01

Outcome

Missed primary endpoint

paper Although the primary endpoint was not statistically significant, analgesia was more pronounced and obtained earlier in the clonidine group. PMID 20299988 ↗

Publications

Wallet F, Clement HJ, Bouret C, Lopez F, Broisin F, Pignal C, Schoeffler M, Derre E, Charpiat B, Huissoud C, Aubrun F, Viale JP. Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 May;27(5):441-7. doi: 10.1097/EJA.0b013e3283365944.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clonidine	Other / unclassified	2 ug/ml	Other
Background	Levobupivacaine	Other / unclassified	0.0625 %	Other
Background	Sufentanil	Other / unclassified	0.25 ug/ml	Other

Indications

No indication recorded.