Systematic Clonidine for Epidural Analgesia in Labour

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Labour

Intervention / Treatment
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* Drug: Clonidine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clonidine<br> | Drug: Clonidine<br>* 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.<br>|
| Other: no clonidine<br> | Drug: Clonidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of required additional epidural boluses, either self-administered or medically given as a rescue |  | during labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous pain during labour (on VAS) |  | during labour | 
| Pain at delivery |  | at delivery | 
| Pain at post-delivery sutures |  | at post-delivery sutures | 
| Motor block |  | during labour | 
| Duration of labour |  | during labour | 
| Obstetrical events (caesarean section, instrumental delivery) |  | after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labour, Epidural analgesia, Clonidine, Levobupivacaine, Opiates, Patient-controlled, Active spontaneous labour requiring epidural analgesia