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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01082744
First received: March 8, 2010
Last updated: May 21, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    using the Visual Analogue Scale (VAS) score

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

  • Patient satisfaction [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Chronic pain [ Time Frame: 3 and 6 monthes ] [ Designated as safety issue: No ]
    assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.


Estimated Enrollment: 87
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082744

Contacts
Contact: Christian BAUER, MD +33472118953 christian.bauer@chu-lyon.fr

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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01082744     History of Changes
Other Study ID Numbers: 2009.558, 2009-014832-38
Study First Received: March 8, 2010
Last Updated: May 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 18, 2014