Ultrasound-guided PVB (BPV échoguidé)
|ClinicalTrials.gov 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
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|
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)|
|Official Title:||Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy|
|Study Start Date :||April 2013|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Experimental: ultrasoundguided paravertebral catheter
ultrasoundguided paravertebral catheter
Device: ultrasoundguided paravertebral catheter
Other Name: ultrasound-guided paravertebral catheterisation
- 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)
- 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
- Paravertebral block catheterisation [ Time Frame: 24 hours ]•Paravertebral catheterisation efficiency
- Paravertebral block efficiency [ Time Frame: 24 hours ]Paravertebral block efficiency
- 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
- Tolerance hemodynamic, nausea and vomiting [ Time Frame: 72 hours ]Tolerance hemodynamic, nausea and vomiting reporting
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842698
|Centre de lautte contre le cancer - Centre Jean Perrin|
|Clermont-Ferrand, France, 63000|
|Principal Investigator:||Hammou TAHERI, PhD||Centre de lutte contre le cancer - Centre Jean Perrin|