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Completed

NCT Number: NCT00983125

Systematic Clonidine for Epidural Analgesia in Labour

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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Key information

Conditions

Labour

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonidine

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.

Primary outcomes

  1. Number of required additional epidural boluses, either self-administered or medically given as a rescue

    Time frame: during labour

Secondary outcomes

  1. Spontaneous pain during labour (on VAS)

    Time frame: during labour

  2. Pain at delivery

    Time frame: at delivery

  3. Pain at post-delivery sutures

    Time frame: at post-delivery sutures

  4. Motor block

    Time frame: during labour

  5. Duration of labour

    Time frame: during labour

  6. Obstetrical events (caesarean section, instrumental delivery)

    Time frame: after delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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 µg.mL-1)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2009
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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