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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437996

Enrollment

Registered

2007-02-21

Start date

2007-02-28

Completion date

2008-01-31

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pregnancy

Keywords

Labor analgesia - clonidine - epidural

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.

Interventions

DRUGClonidine

DRUGLevobupivacaine

DRUGSufentanil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026