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OpenTrials
Completed

NCT Number: NCT00621907

Study : LEVOBUPIVACAINE Versus 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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chirocaine (Levobupivacaine)

Drug

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

Sodium Chloride

Drug

sodium chloride : 0,9% 30 ml

Primary outcomes

  1. analgesic consumption of level 3 in the two treated groups

    Time frame: 24 hours

Secondary outcomes

  1. visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation

    Time frame: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

Acronym: LEVOBU

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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