Ultrasound-guided PVB (BPV échoguidé)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01842698
Recruitment Status : Terminated (The study was stopped because there was a technical problem with the ultrasound used in the trial.)
First Posted : April 30, 2013
Last Update Posted : March 20, 2014
Information provided by (Responsible Party):
Centre Jean Perrin

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.

Condition or disease Intervention/treatment Phase
Thoracotomy Surgery Anesthesia Ultrasound-guided PVB Post-operative Pain Device: ultrasoundguided paravertebral catheter Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ultrasoundguided paravertebral catheter
ultrasoundguided paravertebral catheter
Device: ultrasoundguided paravertebral catheter
Other Name: ultrasound-guided paravertebral catheterisation

Primary Outcome Measures :
  1. The overall failure rate of the para-vertebral block [ Time Frame: 24 hours ]
    The overall failure rate of the para-vertebral block ( failed installation or efficiency)

Secondary Outcome Measures :
  1. The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining [ Time Frame: 24 hours ]
    Effective para-vertebral block obtaining

  2. Paravertebral block catheterisation [ Time Frame: 24 hours ]
    •Paravertebral catheterisation efficiency

  3. Paravertebral block efficiency [ Time Frame: 24 hours ]
    Paravertebral block efficiency

  4. Pain evaluation [ Time Frame: H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h ]
    •Pain evaluation with Analogic Visual Scale

  5. Tolerance hemodynamic, nausea and vomiting [ Time Frame: 72 hours ]
    Tolerance hemodynamic, nausea and vomiting reporting

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01842698

Centre de lautte contre le cancer - Centre Jean Perrin
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Centre Jean Perrin
Principal Investigator: Hammou TAHERI, PhD Centre de lutte contre le cancer - Centre Jean Perrin

Responsible Party: Centre Jean Perrin Identifier: NCT01842698     History of Changes
Other Study ID Numbers: BPVéchoguidé
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Centre Jean Perrin:
Thoracotomy surgery
Ultrasound-guided PVB
Post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms