Evaluation of postoperative pain management with thoracic paravertebral block using levobupivacaine associated with sufentanil - ND

Conditions: postoperative pain
MedDRA version: 9.1Level: LLTClassification code 10036286Term: Post-operative pain

Registration Number: EUCTR2008-005712-40-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

: patients between 35 and 75 years old, ASA class II ? III, undergoing elective thoracic surgery (lobectomy, atypical resection, pneumonectomy, VATS)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who do not express their consent to the use of the technique
Patients with infected site of puncture or sepsis
Patients with a history of allergy to local anesthetics
Patients with psychiatric disease
Patients unable to understand the post-operative evaluation scores
Patients with severe coagulopathy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first end-point of the study is to assess the effectiveness of postoperative pain management with thoracic paravertebral block adding sufentanil to a lower dose of levobupivacaine. A decresed dosage of levobupivacaine reduces the risk of toxicity of the local anaesthetic;Secondary Objective: The second end-point is to assess the safety of paravertebral administration of sufentanil at the dosage we use.;Primary end point(s): The first end-point of the study is to assess the effectiveness of postoperative pain management with thoracic paravertebral block adding sufentanil to a lower dose of levobupivacaine. A decresed dosage of levobupivacaine reduces the risk of toxicity of the local anaesthetic.

Secondary Outcome Measures