- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579276
Different Approaches to Thoracic Paravertebral Block (VAP BLOCK)
Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).
Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hôpitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female ≥ 18 years of age.
- VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
- Signed consent.
- Scheduled surgeries.
Exclusion Criteria:
- Patient refusing to sign the consent form.
- Minors.
- Patients under any guardianship.
- All surgeries with pleura intervention: talc, pleurectomy, wall resection.
- Non trained anesthesiologist to ultrasound TPB.
- Presence of pain or daily use of painkillers prior to surgery.
- Medical history of homolateral thoracic surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "surgical" method
|
Intrathoracic method undergone through video assisted surgery (VATS
|
|
Active Comparator: "anesthetic" method
|
locoregional analgesia under ultrasound control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total morphine consumption
Time Frame: 48 HOURS
|
48 HOURS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time occupancy of the operating room
Time Frame: 1 MONTH
|
1 MONTH
|
|
visual analog scale of pain (VAS)
Time Frame: 12 HOURS
|
12 HOURS
|
|
visual analog scale of pain (VAS)
Time Frame: 48HOURS
|
48HOURS
|
|
visual analog scale of pain (VAS)
Time Frame: 30 DAYS
|
30 DAYS
|
Collaborators and Investigators
Investigators
- Study Director: Emilie GARRIDO- PRADALIE, Assistance Publique Hôpitaux de Marseille
- Principal Investigator: JOSEPHINE CHENESSEAU, Assistance Publique Hôpitaux de Marseille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-11
- 2020-A00483-36 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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