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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University Hospital, Brest.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01023854
First received: December 1, 2009
Last updated: September 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Indication for Renal and/or Adrenal Surgery
Procedure: Continuous Paravertebral block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • morphine consumption during the first 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Paravertebral block
Continuous Paravertebral block
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.

Placebo Comparator: Placebo
Placebo
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023854

Locations
France
Cavale Blanche Hospital
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: François LION, Doctor Brest, Hospital University
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01023854     History of Changes
Other Study ID Numbers: BPV, RB 09.011
Study First Received: December 1, 2009
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Paravertebral block
loco regional anesthesia
renal surgery
PCA morphine

ClinicalTrials.gov processed this record on April 17, 2014