Levobupivacaine for Epidural Analgesia in Labour

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00929682
First received: June 26, 2009
Last updated: April 2, 2013
Last verified: April 2013

June 26, 2009
April 2, 2013
June 2007
March 2008   (final data collection date for primary outcome measure)
- Spontaneous pain during labour (on VAS). - Number of required additional epidural boluses, either self-administered or medically given as a rescue. [ Time Frame: during labour ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00929682 on ClinicalTrials.gov Archive Site
- Pain at delivery - Pain at post-delivery sutures - Motor block - Duration of labour - Obstetrical events (cesarean, instrumental delivery) [ Time Frame: during labour ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Levobupivacaine for Epidural Analgesia in Labour
Not Provided

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Analgesia, Epidural
Drug: Randomization 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.

  • Experimental: Levobupivacaine 0.568mg.mL
    Intervention: Drug: Randomization between two referenced treatments
  • Levobupivacaine 1.136mg.mL
    Intervention: Drug: Randomization between two referenced treatments
Tixier S, Bonnin M, Bolandard F, Vernis L, Lavergne B, Bazin JE, Dualé C. Continuous patient-controlled epidural infusion of levobupivacaine plus sufentanil in labouring primiparous women: effects of concentration. Anaesthesia. 2010 Jun;65(6):573-80. doi: 10.1111/j.1365-2044.2010.06369.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00929682
CHU-0055
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Martine Bonnin, MB University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP