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NCT02865226 Clinical Trial

Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

Pain Clinical Trial

— PVBS-USguided  

Official title:
Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02865226
Other study ID # PA15082
Secondary ID
Status Recruiting
Phase Phase 3
First received August 9, 2016
Last updated August 11, 2016
Start date December 2015
Est. completion date August 2017

Study information
Verified date August 2016
Source CHU de Reims
Contact Jean-Marc MALINOVSKY
Email jmmalinovsky@chu-reims.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.

Description:

Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection

- patient consenting to participate to the study

- patient enrolled in the national healthcare insurance program

- patient older than 18 years

Exclusion Criteria:

- patient with neuropathy

- patient with body mass index superior to 35 kg/m2

- patient with contraindication for paravertebral block or local analgesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

• paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

Locations
Country Name City State
France Chu de Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain Pain evaluated using a visual analog pain scale 24 hours No
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