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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082744
First Posted: March 9, 2010
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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.

Condition Intervention Phase
Pain, Postoperative Drug: Ropivacaine + Sufentanil Drug: Ropivacaine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • morphine consumption during the first 48 hours [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • Acute pain [ Time Frame: 48 hours ]
    using the Visual Analogue Scale (VAS) score

  • Biological measurements [ Time Frame: 48 hours ]
    Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate

  • Patient satisfaction [ Time Frame: 48 hours ]
  • Chronic pain [ Time Frame: 3 and 6 monthes ]
    assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.


Enrollment: 90
Study Start Date: March 2010
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous paravertebral block with ropivacaine Drug: Ropivacaine
Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
Experimental: Continuous paravertebral block with ropivacaine and sufentanil 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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082744


Locations
France
Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Christian BAUER, MD Hospices Civils de Lyon, Hopital Louis Pradel
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01082744     History of Changes
Other Study ID Numbers: 2009.558
2009-014832-38 ( EudraCT Number )
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Hospices Civils de Lyon:
Paravertebral Block
Regional Anesthesia
Anesthetics Local
Ropivacaine
Sufentanil
Pain Postoperative
Chronic Pain
Thoracic Surgery Video-Assisted.

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General