Systematic Clonidine for Epidural Analgesia in Labour

Labour Clinical Trial

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 µg.mL-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983125
• Other study ID #: CHU-0058
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2009
• Last updated: April 2, 2013
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Labour

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Bazin M, Bonnin M, Storme B, Bolandard F, Vernis L, Lavergne B, Pereira B, Bazin JE, Dualé C. Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of required additional epidural boluses, either self-administered or medically given as a rescue		during labour	Yes
Secondary	Spontaneous pain during labour (on VAS)		during labour	Yes
Secondary	Pain at delivery		at delivery	Yes
Secondary	Pain at post-delivery sutures		at post-delivery sutures	Yes
Secondary	Motor block		during labour	Yes
Secondary	Duration of labour		during labour	Yes
Secondary	Obstetrical events (caesarean section, instrumental delivery)		after delivery	Yes

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