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

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Normal Pregnancy

Intervention: Clonidine (Drug); Levobupivacaine (Drug); Sufentanil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
HENRI-JACQUES CLEMENT, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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

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

Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse, Lyon 69004, France

Henri Jacques CLEMENT, Lyon 69000, France

Additional Information

Starting date: February 2007
Last updated: June 26, 2009

Page last updated: August 23, 2015

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