Ultrasound-guided PVB

NCT01842698 | Terminated Phase 2

• 1 other identifier: BPVéchoguidé
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracotomy Surgery; Anesthesia; Ultrasound-guided PVB; Post-operative Pain

Keywords

Thoracotomy surgery; Anesthesia; Ultrasound-guided PVB; Post-operative pain

Outcome Measures

Primary Outcomes (1)

• The overall failure rate of the para-vertebral block

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

  24 hours

Secondary Outcomes (5)

• The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining

  24 hours

• Paravertebral block catheterisation

  24 hours

• Paravertebral block efficiency

  24 hours

• Pain evaluation

  H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h

• Tolerance hemodynamic, nausea and vomiting

  72 hours

Study Arms (1)

ultrasoundguided paravertebral catheter

EXPERIMENTAL

ultrasoundguided paravertebral catheter

Device: ultrasoundguided paravertebral catheter

Interventions

ultrasoundguided paravertebral catheter DEVICE

Also known as: ultrasound-guided paravertebral catheterisation

ultrasoundguided paravertebral catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre de lautte contre le cancer - Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hammou TAHERI, PhD

  Centre de lutte contre le cancer - Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

FR (1)