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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine + Sufentanil; Drug: Ropivacaine

• Registration Number: NCT01082744
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous paravertebral block with ropivacaine and sufentanil	Ropivacaine + Sufentanil	-
Continuous paravertebral block with ropivacaine	Ropivacaine	-

Primary Outcome Measures

Name	Time	Method
morphine consumption during the first 48 hours	48 hours

Secondary Outcome Measures

Name	Time	Method
Acute pain	48 hours	using the Visual Analogue Scale (VAS) score
Patient satisfaction	48 hours
Chronic pain	3 and 6 monthes	assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.
Biological measurements	48 hours	Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate

Trial Locations

Locations (1)

Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology; 🇫🇷 Bron, France