Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy (BPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023854
Recruitment Status : Terminated (No more potentiel patients for study)
First Posted : December 2, 2009
Last Update Posted : July 30, 2014
Information provided by (Responsible Party):
University Hospital, Brest

December 1, 2009
December 2, 2009
July 30, 2014
October 2009
September 2012   (Final data collection date for primary outcome measure)
morphine consumption during the first 24 hours [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01023854 on Archive Site
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Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy
Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults

The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.

The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.

The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Indication for Renal and/or Adrenal Surgery
Procedure: Continuous Paravertebral block

The paravertébral block is a peripheral block which gets an one-sided continuous analgesia by infiltration of the spinal nerves which appear from the intervertebral foramen.

Its realization consists of a draining in 2-3 cm of the thorny apophyses ( T6-T8). During the perception of the osseous contact (cross-functional process of the vertebra), the needle is redirected in cephalic direction until a loss of resistance corresponding to the passage of the upper costo-cross-functional ligament that is in the entrance to the paravertébral space. A catheter is then inserted into the paravertébral space.

  • Experimental: Continuous Paravertebral block
    Continuous Paravertebral block
    Intervention: Procedure: Continuous Paravertebral block
  • Placebo Comparator: Placebo
    Intervention: Procedure: Continuous Paravertebral block
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2013
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Patient scheduled for renal and/or adrenal surgery
  • American Society of Anesthesiologists score ASA I, II, III
  • Written informed consent given by the patient

Exclusion Criteria:

  • Contraindication in the loco-regional anesthesia in the products of local anesthetic
  • Surgery as a matter of urgency
  • Pregnancy
  • Congestive Cardiac insufficiency
  • Severe hepatic Incapacity
  • Disturbs of the coagulation
  • Age < 18 years
  • ASA IV
  • Patient already participating in a study or deadline 3-month-old subordinate since the end of a previous study
  • Under guardianship Patient
  • Psychiatric pathology or limitation of the intellectual abilities making difficult the understanding of the subjective questions.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
RB 09.011 ( Registry Identifier: AFSSAPS A90622-20 )
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University Hospital, Brest
University Hospital, Brest
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Principal Investigator: François LION, Doctor Brest, Hospital University
University Hospital, Brest
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP