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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2014

Interventions

  • 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
  • Drug: Ropivacaine
    • Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Arms, Groups and Cohorts

  • Active Comparator: Continuous paravertebral block with ropivacaine
  • Experimental: Continuous paravertebral block with ropivacaine and sufentanil

Clinical Trial Outcome Measures

Primary Measures

  • morphine consumption during the first 48 hours
    • Time Frame: 48 hours

Secondary 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian BAUER, MD, Principal Investigator, Hospices Civils de Lyon, Hopital Louis Pradel

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.