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

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	24 hours

Collaborators and Investigators

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

Study record dates

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: Paravertebral block; PCA morphine; loco regional anesthesia; renal surgery
• Other Study ID Numbers: BPV; RB 09.011 (Registry Identifier: AFSSAPS A90622-20)