Ultrasound-guided PVB

Phase 2

Terminated

• Conditions: Ultrasound-guided PVB; Thoracotomy Surgery; Anesthesia; Post-operative Pain
• Interventions: Device: ultrasoundguided paravertebral catheter

• Registration Number: NCT01842698
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-02-14
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasoundguided paravertebral catheter	ultrasoundguided paravertebral catheter	ultrasoundguided paravertebral catheter

Primary Outcome Measures

Name	Time	Method
The overall failure rate of the para-vertebral block	24 hours	The overall failure rate of the para-vertebral block ( failed installation or efficiency)

Secondary Outcome Measures

Name	Time	Method
Paravertebral block efficiency	24 hours	Paravertebral block efficiency
Pain evaluation	H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h	•Pain evaluation with Analogic Visual Scale
Tolerance hemodynamic, nausea and vomiting	72 hours	Tolerance hemodynamic, nausea and vomiting reporting
The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining	24 hours	Effective para-vertebral block obtaining
Paravertebral block catheterisation	24 hours	•Paravertebral catheterisation efficiency

Trial Locations

Locations (1)

Centre de lautte contre le cancer - Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France