Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Information source: Hospices Civils de Lyon
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Normal Pregnancy
Intervention: Clonidine (Drug); Levobupivacaine (Drug); Sufentanil (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hospices Civils de Lyon Official(s) and/or principal investigator(s):
HENRI-JACQUES CLEMENT, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon
Overall contact:
HENRI-JACQUES CLEMENT, MD, Phone: +33472071664, Email: henri-jacques.clement@chu-lyon.fr
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.
Clinical Details
Official title: Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Score of quality at the time of the childbirth based on a 4-point scale : motor blockade – no sensation - nonpainful sensation - pain.
Secondary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
HENRI-JACQUES CLEMENT, MD, Phone: +33472071664, Email: henri-jacques.clement@chu-lyon.fr
Anesthesie Reanimation - Gynecologie - Hopital De La Croix Rousse, LYON 69004, France; Recruiting
HENRI-JACQUES CLEMENT, MD, Phone: +33472071664, Email: henri-jacques.clement@chu-lyon.fr
JEAN-PAUL VIALE, MD, PhD, Phone: +33472072426, Email: jean-paul.viale@chu-lyon.fr
Additional Information
Starting date: February 2007
Ending date: February 2008
Last updated: April 26, 2007
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