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Levobupivacaine for Epidural Analgesia in Labour

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929682
Enrollment
136
Registered
2009-06-29
Start date
2007-06-30
Completion date
2008-03-31
Last updated
2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Epidural

Keywords

Labor, Epidural analgesia, Local anesthetics, Levobupivacaine, Opiates, Patient-controlled, Active spontaneous labor requiring epidural analgesia

Brief summary

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

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.

Interventions

DRUGRandomization between two referenced treatments

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
- Pain at delivery - Pain at post-delivery sutures - Motor block - Duration of labour - Obstetrical events (cesarean, instrumental delivery)during labour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026