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Ultrasound-guided PVB (BPV échoguidé)

Primary Purpose

Thoracotomy Surgery, Anesthesia, Ultrasound-guided PVB

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ultrasoundguided paravertebral catheter
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracotomy Surgery focused on measuring Thoracotomy surgery, Anesthesia, Ultrasound-guided PVB, Post-operative pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing programmed lateral or posterolateral thoracotomy, regardless of indication,
  • Aged 18 to 80 years

Exclusion Criteria:

  • Surgery performed in the emergency;
  • Specific clinical contexts including neoplasia in terminal phase or palliative phase;
  • Contraindications to the products of the study

Sites / Locations

  • Centre de lautte contre le cancer - Centre Jean Perrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasoundguided paravertebral catheter

Arm Description

ultrasoundguided paravertebral catheter

Outcomes

Primary Outcome Measures

The overall failure rate of the para-vertebral block
The overall failure rate of the para-vertebral block ( failed installation or efficiency)

Secondary Outcome Measures

The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining
Effective para-vertebral block obtaining
Paravertebral block catheterisation
•Paravertebral catheterisation efficiency
Paravertebral block efficiency
Paravertebral block efficiency
Pain evaluation
•Pain evaluation with Analogic Visual Scale
Tolerance hemodynamic, nausea and vomiting
Tolerance hemodynamic, nausea and vomiting reporting

Full Information

First Posted
February 14, 2013
Last Updated
March 19, 2014
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT01842698
Brief Title
Ultrasound-guided PVB
Acronym
BPV échoguidé
Official Title
Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped because there was a technical problem with the ultrasound used in the trial.
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management. Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB. Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning. The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component. Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac. This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.
Detailed Description
Prospective followed of cohort including consecutive patients, all receiving the same technique of anesthesia and analgesia: Preoperative para-vertebral catheterisation on the surgery side. Preoperative test of the efficiency of para-vertebral block. Conventional general anesthesia. Conventional rescue postoperative analgesia. Systematic radiographic control with injection of contrast product into the para-vertebral catheter. Conventional postoperative monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracotomy Surgery, Anesthesia, Ultrasound-guided PVB, Post-operative Pain
Keywords
Thoracotomy surgery, Anesthesia, Ultrasound-guided PVB, Post-operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasoundguided paravertebral catheter
Arm Type
Experimental
Arm Description
ultrasoundguided paravertebral catheter
Intervention Type
Device
Intervention Name(s)
ultrasoundguided paravertebral catheter
Other Intervention Name(s)
ultrasound-guided paravertebral catheterisation
Primary Outcome Measure Information:
Title
The overall failure rate of the para-vertebral block
Description
The overall failure rate of the para-vertebral block ( failed installation or efficiency)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining
Description
Effective para-vertebral block obtaining
Time Frame
24 hours
Title
Paravertebral block catheterisation
Description
•Paravertebral catheterisation efficiency
Time Frame
24 hours
Title
Paravertebral block efficiency
Description
Paravertebral block efficiency
Time Frame
24 hours
Title
Pain evaluation
Description
•Pain evaluation with Analogic Visual Scale
Time Frame
H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h
Title
Tolerance hemodynamic, nausea and vomiting
Description
Tolerance hemodynamic, nausea and vomiting reporting
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing programmed lateral or posterolateral thoracotomy, regardless of indication, Aged 18 to 80 years Exclusion Criteria: Surgery performed in the emergency; Specific clinical contexts including neoplasia in terminal phase or palliative phase; Contraindications to the products of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hammou TAHERI, PhD
Organizational Affiliation
Centre de lutte contre le cancer - Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de lautte contre le cancer - Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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Ultrasound-guided PVB

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