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

Indication for Renal and/or Adrenal Surgery Clinical Trial

— BPV  

Official title:

Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01023854
• Other study ID #: BPV
• Secondary ID: RB 09.011
• Status: Terminated
• Phase: N/A
• First received: December 1, 2009
• Last updated: July 29, 2014
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Indication for Renal and/or Adrenal Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Cavale Blanche Hospital	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption during the first 24 hours		24 hours	No