Levobupivacaine 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 > 7 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%, or 0.125%, in which 10 mL (50 µg) of sufentanil will be added. The final concentrations will be 0.568 and 1.136 mg.mL-1 respectively, both with sufentanil 0.45 µg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design

Detailed Description
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Since epidural analgesia has been developed to relieve labour pain, many solutions have emerged to lower risk / efficacy ratio, by using low-concentrated and/or less toxic local anaesthetics. Levobupicaine emerges as a safer alternative than its racemic parent . It is available on the French market in pre-filled bags with two different concentrations (0.625 and 1.25 mg.mL-1), both indicated for analgesia in postoperative context and in labour, without more precision. Presentation in bags allows preparing once at the initiation of epidural analgesia a solution usable throughout labour, leading the anaesthetist to a univocal choice, mostly following his/her personal beliefs. Our aim is to compare the effects of epidural analgesia under these two presentations. Sufentanil will be added to levobupicaine whatever the concentration used. This trial is conducted in primiparous, in which pain during labour is commonly more resistant to relief.

Conditions
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Analgesia, Epidural

Intervention / Treatment
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* Drug: Randomization between two referenced treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturient > 18 years old ASA physical status 1 or 2 Primiparity Singleton Gestational age > 36 weeks Spontaneous labour with cervical dilatation > 7 cm Exclusion Criteria: Gestational age < 36 weeks

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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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levobupivacaine 0.568mg.mL<br> | Drug: Randomization between two referenced treatments<br>* Levobupivacaine 0.568 mg.mL-1 and sufentanil 0.45 g.mL-1, 20 mL epidurally for induction, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. Same protocol, with levobupivacaine 1.136 mg.mL-1 and sufentanil 0.45 g.mL-1.<br>|
| Other: Levobupivacaine 1.136mg.mL<br> | Drug: Randomization between two referenced treatments<br>* Levobupivacaine 0.568 mg.mL-1 and sufentanil 0.45 g.mL-1, 20 mL epidurally for induction, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. Same protocol, with levobupivacaine 1.136 mg.mL-1 and sufentanil 0.45 g.mL-1.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Epidural analgesia, Local anesthetics, Levobupivacaine, Opiates, Patient-controlled, Active spontaneous labor requiring epidural analgesia