Systematic Clonidine for Epidural Analgesia in Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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clonidine

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.

To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.

no clonidine

Group Type OTHER

Clonidine

Intervention Type DRUG

Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.

To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.

Interventions

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Clonidine

Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.

To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes