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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ropivacaine + Sufentanil
Ropivacaine
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Paravertebral Block, Regional Anesthesia, Anesthetics Local, Ropivacaine, Sufentanil, Pain Postoperative, Chronic Pain, Thoracic Surgery Video-Assisted.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous paravertebral block with ropivacaine

Continuous paravertebral block with ropivacaine and sufentanil

Arm Description

Outcomes

Primary Outcome Measures

morphine consumption during the first 48 hours

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2010
Last Updated
March 18, 2015
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01082744
Brief Title
Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.
Acronym
PARAVI
Official Title
Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Paravertebral Block, Regional Anesthesia, Anesthetics Local, Ropivacaine, Sufentanil, Pain Postoperative, Chronic Pain, Thoracic Surgery Video-Assisted.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous paravertebral block with ropivacaine
Arm Type
Active Comparator
Arm Title
Continuous paravertebral block with ropivacaine and sufentanil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ropivacaine + Sufentanil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
Primary Outcome Measure Information:
Title
morphine consumption during the first 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Acute pain
Description
using the Visual Analogue Scale (VAS) score
Time Frame
48 hours
Title
Biological measurements
Description
Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate
Time Frame
48 hours
Title
Patient satisfaction
Time Frame
48 hours
Title
Chronic pain
Description
assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.
Time Frame
3 and 6 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian BAUER, MD
Organizational Affiliation
Hospices Civils de Lyon, Hopital Louis Pradel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29373333
Citation
Bauer C, Pavlakovic I, Mercier C, Maury JM, Koffel C, Roy P, Fellahi JL. Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.
Results Reference
derived

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

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