Paravertebral block: influence of Body Mass Index on the dosage of local anaesthetic. - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006445-18-IT

Enrollment

120

Registered

2008-10-29

Start date

2010-09-23

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain MedDRA version: 9.1 Level: LLT Classification code 10064882 Term: Procedural pain

Interventions

Trade Name: NAROPINA 7,5MG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients between 30 and 75 years old, ASA class I - 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 aim of our study is to confront the analgesic efficacy of a weight-related infusion rate (0.1-0.15 ml/kg/h) with a standardized one (5 ml/h) during Paravertebral block.;Secondary Objective: nd;Primary end point(s): The first end-point of the study is to confront the analgesic efficacy of a weight-related infusion rate (0.1-0.15 ml/kg/h) with a standardized one (5 ml/h) during Paravertebral Block. The second end-point is to assess the requirements of supplementary analgesic and the incidence of complications.	—

Measure

Time frame

Main Objective: The aim of our study is to confront the analgesic efficacy of a weight-related infusion rate (0.1-0.15 ml/kg/h) with a standardized one (5 ml/h) during Paravertebral block.;Secondary Objective: nd;Primary end point(s): The first end-point of the study is to confront the analgesic efficacy of a weight-related infusion rate (0.1-0.15 ml/kg/h) with a standardized one (5 ml/h) during Paravertebral Block. The second end-point is to assess the requirements of supplementary analgesic and the incidence of complications.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026