Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.

Pain, Postoperative Clinical Trial

— PARAVI  

Official title:

Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082744
• Other study ID #: 2009.558
• Secondary ID: 2009-014832-38
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2010
• Last updated: March 18, 2015
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Hospices Civils de Lyon
• 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 use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for planned video-assisted thoracic surgery

• Patient that consent to participate

• Planned placement of paravertebral catheter

• Patient having a medical insurance

Exclusion Criteria:

• Patient less than 18 years

• Refusal to participate

• Known pregnancy

• Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material

• Intolerance to sufentanil and/or morphine

• Chronic consumption of opiates

• Preoperative chronic pain syndrome

• Patient having a contraindication to placement of paravertebrtal catheter

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine + Sufentanil
Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
• Ropivacaine
Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption during the first 48 hours		48 hours	No
Secondary	Acute pain	using the Visual Analogue Scale (VAS) score	48 hours	No
Secondary	Biological measurements	Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate	48 hours	Yes
Secondary	Patient satisfaction		48 hours	No
Secondary	Chronic pain	assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.	3 and 6 monthes	No