- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00621907
Study : LEVOBUPIVACAINE Versus Placebo (LEVOBU)
Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Saint-Etienne, Frankrig, 42055
- University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
patient who received levobupivacaïne
|
levobupivacaine 0,5 % 30 ml infiltration (150 mg)
|
Placebo komparator: 2
patient who received placebo
|
sodium chloride : 0,9% 30 ml
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
analgesic consumption of level 3 in the two treated groups
Tidsramme: 24 hours
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation
Tidsramme: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month
|
hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Céline CHAULEUR, MD, CHU de Saint-Etienne
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0708097
- 2007-006275-36
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