Skip to main content
OpenTrials
Completed

NCT Number: NCT00437996

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Normal Pregnancy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of ASA class I or II
  • Variable parity
  • Aged of 18 years or more
  • With a normal pregnancy
  • Cervical dilation between 3 and 8 cm)
  • Wishing an epidural analgesia
  • Normal childbirth
  • Giving their written assent
  • Affiliated with a social security system
  • Must have had an anaesthesia consultation more than 48 hours before inclusion.

Exclusion criteria

  • Request of the patient
  • Failure of epidural analgesia
  • Childbirth in the 90 minutes following the induction of analgesia
  • Realization of a Caesarean section

Treatment and study plan

Clonidine

Drug

Levobupivacaine

Drug

Sufentanil

Drug

Primary outcomes

  1. Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.

Secondary outcomes

  1. Motor blockade quantification by a score of modified Bromage specific way.

  2. Labor analgesia.

  3. Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil

Important dates

Study start
2007
Study completion
2008
First posted
Feb 21, 2007
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.