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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
History of Changes
  Purpose

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 Intervention Phase
Analgesia, Epidural
 Drug: Randomization between two referenced treatments
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 136
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929682

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00929682     History of Changes
Other Study ID Numbers: CHU-0055
Study First Received: June 26, 2009
Last Updated: April 2, 2013
Health Authority: France: Ministry of Health

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
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013