Completed

LEVOBULevobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

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What is being tested

chirocaine (Levobupivacaine)

+ sodium chloride

Drug
Who is being recruted

Neurologic Manifestations+1

+ Pain

+ Signs and Symptoms

From 18 to 50 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2008
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Saint Etienne
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2008

Actual date on which the first participant was enrolled.

The study will be done at the department of Obstétric and gynecology, in the CHU of Saint-Etienne. It will include all patients requiring a caesarean without any contraindication. All the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done. Inclusion after information and minimum one hour of time for consideration. Randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall. Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.

Official TitleLevobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
NCT00621907
Principal SponsorCentre Hospitalier Universitaire de Saint Etienne
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
age > 18 years

all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique

5 exclusion criteria prevent from participating
Patients requiring very urgent caesarian

allergic to levobupivacaïne

with previous history of alcoholism or drug addiction

with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
patient who received levobupivacaïne

Group II

Placebo
patient who received placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospital

Saint-Etienne, FranceOpen University Hospital in Google Maps
CompletedOne Study Center