Ultrasound-guided PVB (BPV échoguidé)

This study has been terminated.
(The study was stopped because there was a technical problem with the ultrasound used in the trial.)
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01842698
First received: February 14, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Thoracotomy Surgery
Anesthesia
Ultrasound-guided PVB
Post-operative Pain
Device: ultrasoundguided paravertebral catheter
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • The overall failure rate of the para-vertebral block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Effective para-vertebral block obtaining

  • Paravertebral block catheterisation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    •Paravertebral catheterisation efficiency

  • Paravertebral block efficiency [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Paravertebral block efficiency

  • Pain evaluation [ Time Frame: H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h ] [ Designated as safety issue: No ]
    •Pain evaluation with Analogic Visual Scale

  • Tolerance hemodynamic, nausea and vomiting [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Tolerance hemodynamic, nausea and vomiting reporting


Estimated Enrollment: 60
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ultrasoundguided paravertebral catheter
ultrasoundguided paravertebral catheter
Device: ultrasoundguided paravertebral catheter
Other Name: ultrasound-guided paravertebral catheterisation

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842698

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

No publications provided

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01842698     History of Changes
Other Study ID Numbers: BPVéchoguidé
Study First Received: February 14, 2013
Last Updated: March 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014