A comparison of pain relief options after a mastectomy. A paravertebral block in an injection paralell to the spine and blocks the nerves suppling the surgical area. A wound catheter is place in the surgical wound and used to numb the area.

• Conditions: This study will involve the administration of levobupivicaine 0.125% and 0.25%, a local anaesthetic agent licensed for this purpose into the paravertebral space and into the surgical wound, to provide postoperative analgesia for adults having a mastecomy. We aim to compare the analgesia efficacy of paravertebral blockade with surgical wound blockade for post operative pain in the first 48 hours.; MedDRA version: 14.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-002867-40-IE
• Lead Sponsor: Department of Anaesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adults (aged 18-80) presenting for elective mastectomy + axillary surgery
ASA 1 to 3
Written informed consent

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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Patient refusal
Local infection at site of insertion
Allergy to amide local anaesthetics, fentanyl, morphine, paracetamol, volatile anaesthetics
Concurrent use of MAOIs or within 2 weeks of MAOI use
Sepsis
Systemic anticoagulation or coagulopathy
Uncontrolled hypertension
Uncontrolled Diabetes Mellitus
Severe liver or cardiac dysfunction
Inability to comprehend pain scoring system

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified