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Systematic Clonidine for Epidural Analgesia in Labour

Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labour

Intervention: Clonidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Clermont-Ferrand

Official(s) and/or principal investigator(s):
Martine Bonnin, MB, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand

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 g) 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 g.mL-1)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

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

CHU Clermont-Ferrand, Clermont-Ferrand 63003, France
Additional Information

Starting date: August 2009
Last updated: April 2, 2013

Page last updated: August 23, 2015

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