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

This study has been terminated.
(No more potentiel patients for study)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01023854
First received: December 1, 2009
Last updated: July 29, 2014
Last verified: July 2014
  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 ]

Enrollment: 41
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: September 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 29, 2014
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 September 16, 2014