Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
1 other identifier
interventional
85
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 19, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJune 30, 2009
June 1, 2009
February 19, 2007
June 26, 2009
Conditions
Keywords
Outcome Measures
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 (3)
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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Request of the patient
- Failure of epidural analgesia
- Childbirth in the 90 minutes following the induction of analgesia
- Realization of a Caesarean section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Henri Jacques CLEMENT
Lyon, 69000, France
Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse
Lyon, 69004, France
Related Publications (1)
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.
PMID: 20299988DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HENRI-JACQUES CLEMENT, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2007
First Posted
February 21, 2007
Study Start
February 1, 2007
Study Completion
January 1, 2008
Last Updated
June 30, 2009
Record last verified: 2009-06