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Study : LEVOBUPIVACAINE Versus Placebo

Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00621907
Acronym
LEVOBU
Enrollment
140
Registered
2008-02-22
Start date
2008-03-31
Completion date
2009-05-31
Last updated
2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

randomized, analgesic, caesarean scars, locoregional anaesthesia, infiltration, levobupivacaïne, Chirocaïne, caesarian, unique administration, post-caesarian analgesic

Brief summary

The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia. Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique

Detailed description

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.

Interventions

DRUGchirocaine (Levobupivacaine)

levobupivacaine 0,5 % 30 ml infiltration (150 mg)

DRUGsodium chloride

sodium chloride : 0,9% 30 ml

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* age \> 18 years * all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique

Exclusion criteria

* 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 * treated with first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity

Design outcomes

Primary

MeasureTime frame
analgesic consumption of level 3 in the two treated groups24 hours

Secondary

MeasureTime frame
visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operationhours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026