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Levobupivacaine for Epidural Analgesia in Labour

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ClinicalTrials.gov Identifier: NCT00929682
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Analgesia, Epidural Drug: Randomization between two referenced treatments Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : June 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Levobupivacaine 0.568mg.mL 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.

Levobupivacaine 1.136mg.mL 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.




Primary Outcome Measures :
  1. - 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 ]

Secondary Outcome Measures :
  1. - Pain at delivery - Pain at post-delivery sutures - Motor block - Duration of labour - Obstetrical events (cesarean, instrumental delivery) [ Time Frame: during labour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929682


Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Martine Bonnin, MB University Hospital, Clermont-Ferrand

Additional Information:
Publications:
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00929682     History of Changes
Other Study ID Numbers: CHU-0055
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Labor
Epidural analgesia
Local anesthetics
Levobupivacaine
Opiates
Patient-controlled
Active spontaneous labor requiring epidural analgesia

Additional relevant MeSH terms:
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents