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

July 29, 2014 updated by: University Hospital, Brest

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Cavale Blanche Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
morphine consumption during the first 24 hours
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: François LION, Doctor, Brest, Hospital University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BPV
  • RB 09.011 (Registry Identifier: AFSSAPS A90622-20)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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