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

NCT ID: NCT01023854

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-09-30

Brief Summary

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.

Conditions

Indication for Renal and/or Adrenal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Continuous Paravertebral block

Continuous Paravertebral block

Group Type: EXPERIMENTAL

Continuous Paravertebral block

Intervention Type: PROCEDURE

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

Placebo

Group Type: PLACEBO_COMPARATOR

Continuous Paravertebral block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François LION, Doctor

Role: PRINCIPAL_INVESTIGATOR

Brest, Hospital University

Locations

Cavale Blanche Hospital

Brest, , France

Countries

France

Other Identifiers

RB 09.011

Identifier Type: REGISTRY

Identifier Source: secondary_id

BPV

Identifier Type: -

Identifier Source: org_study_id