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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00983125
Other study ID # CHU-0058
Secondary ID
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


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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Recruiting NCT02838329 - Labour Epidural Top-up With Warmed Ropivacaine N/A
Completed NCT03764696 - Maternal Oxygen Administration for Fetal Distress II N/A
Completed NCT03141320 - Confident Birthing: What Influences Women's Confidence for Birth?
Recruiting NCT02116842 - Minimum Effective Dose (MED) & Epidural Bupivacaine Phase 4

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