postoperative pain MedDRA version: 9.1 Level: LLT Classification code 10036286 Term: Post-operative pain
Conditions
Interventions
Trade Name: FENTATIENIL
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sufentanil
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 5-
Trade Name:
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed