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
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
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
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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