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

Normal Pregnancy Clinical Trial

Official title:

Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437996
• Other study ID #: 2006.424
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2007
• Last updated: June 26, 2009
• Start date: February 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2009
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Normal Pregnancy

Intervention

Drug:
• Clonidine

• Levobupivacaine

• Sufentanil

Locations

Country	Name	City	State
France	Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse	Lyon
France	Henri Jacques CLEMENT	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
Secondary	Motor blockade quantification by a score of modified Bromage specific way.
Secondary	Labor analgesia.
Secondary	Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).