Systematic Clonidine for Epidural Analgesia in Labour
Information source: University Hospital, Clermont-Ferrand
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labour
Intervention: Clonidine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s):
Martine Bonnin, MB, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
Overall contact:
Patrick Lacarin, Email: placarin@chu-clermontferrand.fr
Summary
In a prospective randomised study involving primiparous women in spontaneous uncomplicated
labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial
volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual
injections to achieve analgesia, then by a patient-controlled regimen with 5-mL
self-administered boli in addition to a continuous infusion of 5 mL. hr-1. The anaesthetic
solution will be levobupivacaine presented in 100-mL bags from the market (0. 0625%), in
which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm.
The final concentration of clonidine in this arm will be 1. 35 mg. mL-1. Parturients and
midwifes assessing pain during labour will be blinded to the design.
Clinical Details
Official title: Effects of a Systematic Addition of Clonidine in the Local Anaesthetic and Opiate Solution for Epidural Patient Controlled Analgesia in Labour (Levobupivacaine 0.568 mg.mLl-1 + Sufentanil 0.45 µg.mL-1)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Number of required additional epidural boluses, either self-administered or medically given as a rescue
Secondary outcome: Spontaneous pain during labour (on VAS)Pain at delivery Pain at post-delivery sutures Motor block Duration of labour Obstetrical events (caesarean section, instrumental delivery)
Detailed description:
We recently compared the analgesic effects of the two presentations of levobupivacaine
available on the French market, (0. 625 and 1. 25 mg. mL-1 in pre-filled bags), both with
sufentanil. It appeared that the high concentration was more powerful, however leading in
some cases to give doses of levobupivacaine superior to the label's recommendations. This
indicates to use the low concentration, with a risk of a poorer efficacy. Our aim is to show
that efficacy can be restored with a systematic addition of clonidine, which has documented
analgesic properties when administered perispinally.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Parturient is 18 years old
- ASA physical status 1 or 2
- Primiparity
- Singleton
- Gestational age is 36 weeks
- Spontaneous labour with cervical dilatation of 5 cm
Locations and Contacts
Patrick Lacarin, Email: placarin@chu-clermontferrand.fr
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France; Recruiting
Patrick Lacarin, Email: placarin@chu-clermontferrand.fr
Additional Information
Starting date: August 2009
Ending date: September 2010
Last updated: September 22, 2009
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