Ultrasound-guided PVB

Anesthesia Clinical Trial

— BPV échoguidé  

Official title:

Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01842698
• Other study ID #: BPVéchoguidé
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2013
• Last updated: March 19, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Post-operative Pain
• Thoracotomy Surgery
• Ultrasound-guided PVB

Intervention

Device:
• ultrasoundguided paravertebral catheter

Locations

Country	Name	City	State
France	Centre de lautte contre le cancer - Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall failure rate of the para-vertebral block	The overall failure rate of the para-vertebral block ( failed installation or efficiency)	24 hours	No
Secondary	The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining	Effective para-vertebral block obtaining	24 hours	No
Secondary	Paravertebral block catheterisation	•Paravertebral catheterisation efficiency	24 hours	No
Secondary	Paravertebral block efficiency	Paravertebral block efficiency	24 hours	No
Secondary	Pain evaluation	•Pain evaluation with Analogic Visual Scale	H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h	No
Secondary	Tolerance hemodynamic, nausea and vomiting	Tolerance hemodynamic, nausea and vomiting reporting	72 hours	No