Levobupivacaine for Epidural Analgesia in Labour
1 other identifier
interventional
136
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2007
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedApril 4, 2013
April 1, 2013
9 months
June 26, 2009
April 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- Spontaneous pain during labour (on VAS). - Number of required additional epidural boluses, either self-administered or medically given as a rescue.
during labour
Secondary Outcomes (1)
- Pain at delivery - Pain at post-delivery sutures - Motor block - Duration of labour - Obstetrical events (cesarean, instrumental delivery)
during labour
Study Arms (2)
Levobupivacaine 0.568mg.mL
EXPERIMENTALLevobupivacaine 1.136mg.mL
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Parturient \> 18 years old
- ASA physical status 1 or 2
- Primiparity
- Singleton
- Gestational age \> 36 weeks
- Spontaneous labour with cervical dilatation \> 7 cm
You may not qualify if:
- Gestational age \< 36 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tixier S, Bonnin M, Bolandard F, Vernis L, Lavergne B, Bazin JE, Duale C. Continuous patient-controlled epidural infusion of levobupivacaine plus sufentanil in labouring primiparous women: effects of concentration. Anaesthesia. 2010 Jun;65(6):573-580. doi: 10.1111/j.1365-2044.2010.06369.x.
PMID: 20565392RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine Bonnin, MB
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 4, 2013
Record last verified: 2013-04