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A randomised, double-blind, prospective study to compare the analgesic efficacy of 10 ml epidural loading dose levobupivacaine 0.5% versus levobupivacaine 0.25% in patients after major abdominal or thoracic surgery.

A randomised, double-blind, prospective study to compare the analgesic efficacy of 10 ml epidural loading dose levobupivacaine 0.5% versus levobupivacaine 0.25% in patients after major abdominal or thoracic surgery.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000700-32-BE
Enrollment
100
Registered
2007-02-19
Start date
2007-03-20
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

patient controlled epidural pain therapy after major abdominal or thoracic surgery

Interventions

Trade Name: Chirocaine Pharmaceutical Form: Injection* INN or Proposed INN: levobupivacaine CAS Number: 2180-92-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrat

Sponsors

University hospitals Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: abdominal or thoracic surgery with the necessity of a PCEA-system ASA 1,2,3 age of 18 or older 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: coagulation problems chronic pain patient allergy to local anesthetics

Design outcomes

Primary

MeasureTime frame
Main Objective: To record the incidence of a perfect sensoric block after the administration of a epidural loading dose of 10 ml levobupivacaine 0.5% compared with 10ml levobupivacaine 0.25%;Secondary Objective: Evaluation of the hemo-dynamic stability first 3 hours after the administration of the loading dose. To record the incidence of adverse events.;Primary end point(s): Has the epidural administration of 10ml levobupivacaine 0.5% a better analgesic effect compared with 10ml levobupivacaine 0.25% ?—

Countries

Belgium

Outcome results

None listed

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