Ultrasound-guided PVB (BPV échoguidé)

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

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia; Post-operative Pain; Thoracotomy Surgery; Ultrasound-guided PVB
• Intervention / Treatment: Device: ultrasoundguided paravertebral catheter

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre de lautte contre le cancer - Centre Jean Perrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasoundguided paravertebral catheter	Device: ultrasoundguided paravertebral catheter; Other Names: ultrasound-guided paravertebral catheterisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Hammou TAHERI, PhD, Centre de lutte contre le cancer - Centre Jean PERRIN

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Anesthesia; Post-operative pain; Thoracotomy surgery; Ultrasound-guided PVB
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: BPVéchoguidé