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

Phase 3

Completed

• Conditions: Normal Pregnancy

• Registration Number: NCT00437996
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-19
• Study First Submitted QC: 2007-02-19
• Study First Posted: 2007-02-21
• Study Completion: 2008-01
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-26
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Henri Jacques CLEMENT; 🇫🇷 Lyon, France

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