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...
Date First Received: February 19, 2007
Last Updated: June 26, 2009
Verified by: Hospices Civils de Lyon, June 2009
Clinical Trial Phase: Phase 3 | Start Date: February 2007
Overall Status: Completed
Estimated Enrollment: 85
Brief Summary
Official Title: “Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
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 Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Clonidine
- Drug: Levobupivacaine
- Drug: Sufentanil
Outcome Measures for this Clinical Trial
Primary Measures
- Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
Secondary Measures
- 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).
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Hospices Civils de Lyon
Overall Clinical Trial Officials and Contacts
HENRI-JACQUES CLEMENT, MD Principal Investigator Hospices Civils de Lyon
Additional Information
Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437996
Study ID Number: 2006.424
ClinicalTrials.gov Identifier: NCT00437996
Health Authority: France: Afssaps - French Health Products Safety Agency
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