PHARMACOKINETICS AND ANALGESIC EFFICACY OF LAEVOBUPIVACAINE, FENTANYL AND CLONIDINE FOR POSTOPERATIVE PARAVERTEBRAL ANAESTHESIA.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004988-30-IE

Enrollment

Registered

2005-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

We are aiming to provide postoperative analgesia for breast surgery

Interventions

Trade Name: Chirocaine Product Name: Chirocaine Product Code: PA 38/71/1 Pharmaceutical Form: Solution for injection INN or Proposed INN: Levobupivacaine Concentration unit: mg/ml milligram(s)/millili

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting for breast surgery for cancer, who are not day cases and do not have contraindications for paravertebral analgesia will be approached. 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: Day cases Paravertebral analgesia refused or contraindicated Active psychiatric illness Allergy to any of the proposed drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of the proposed study are to evaluate the pharmacokinetics of laevobupivacaine, fentanyl and clonidine by measuring their plasma concentrations at defined time intervals after paravertebral analgesia, and to investigate if fentanyl and clonidine have local anaesthetic–sparing effects when given as adjunctive analgesics for paravertebral analgesia. ;Secondary Objective: The secondary objectives is to provide high degree of postoperative analgesia as measured by the patient's pain anad satisfaction scores. We are aiming for a pain score less than 40 mm on the Visual Analogue Scale with minimal use of intravenous opioids as rescue analgesia and a satisfaction score more than 80 mm on the same scale.;Primary end point(s): The objectives of the proposed study are to evaluate the pharmacokinetics of levobupivacaine, fentanyl and clonidine by measuring their plasma concentrations at defined time intervals after paravertebral analgesia. Primary outcome measure (apart from the plasma levels of the drugs) will be also pain scores on movement, measured on a 100mm visual analogue scale (VAS), recorded at the time of blood sampling postoperatively, and also cumulative Patient Controlled Analgesia morphine consumption over 36 hr. Secondary outcomes will include blood pressure, heart rate, respiratory rate, nausea/vomiting, pruritus, sedation scores and patient satisfaction (also on a 100mm VAS).	—

Measure

Time frame

Main Objective: The objectives of the proposed study are to evaluate the pharmacokinetics of laevobupivacaine, fentanyl and clonidine by measuring their plasma concentrations at defined time intervals after paravertebral analgesia, and to investigate if fentanyl and clonidine have local anaesthetic–sparing effects when given as adjunctive analgesics for paravertebral analgesia. ;Secondary Objective: The secondary objectives is to provide high degree of postoperative analgesia as measured by the patient's pain anad satisfaction scores. We are aiming for a pain score less than 40 mm on the Visual Analogue Scale with minimal use of intravenous opioids as rescue analgesia and a satisfaction score more than 80 mm on the same scale.;Primary end point(s): The objectives of the proposed study are to evaluate the pharmacokinetics of levobupivacaine, fentanyl and clonidine by measuring their plasma concentrations at defined time intervals after paravertebral analgesia. Primary outcome measure (apart from the plasma levels of the drugs) will be also pain scores on movement, measured on a 100mm visual analogue scale (VAS), recorded at the time of blood sampling postoperatively, and also cumulative Patient Controlled Analgesia morphine consumption over 36 hr. Secondary outcomes will include blood pressure, heart rate, respiratory rate, nausea/vomiting, pruritus, sedation scores and patient satisfaction (also on a 100mm VAS).

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Countries

Ireland

Outcome results

None listed

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