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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: 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: CHIROCAINE Pharmaceutical Form: Solution for injection INN or Proposed INN: Levobupivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 7.5‐ CONDITION: postoperative pain ; MedDRA version: 9.1 Level: LLT Classification code 10036286 Term: Post‐operative pain PRIMARY OUTCOME: 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 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 Objective: The second end‐point is to assess the safety of paravertebral administration of sufentanil at the dosage we use. 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
Epistemonikos ID: 9f962ae2579e632f1b357ddf875852268fc04eff
First added on: Aug 21, 2024