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.

Comparsion of continuous paravertebral blockade and continuous wound catheter infiltration for analgesia following mastectomy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002867-40-IE

Enrollment

135

Registered

2011-08-05

Start date

2011-11-22

Completion date

Unknown

Last updated

2025-04-07

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

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: 14.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ C

Interventions

Trade Name: Chirocaine Product Name: Levobupivicaine Product Code: N01BB10 Pharmaceutical Form: Solution for infusion CAS Number: 27262-48-2 Other descriptive name: LEVOBUPIVACAINE HYDROCHLORIDE Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to compare the analgesic efficacy of continuous paravertebral blockade and continuous wound infiltration with a control, for post operative pain in the first 48 post operative hours, following mastectomy and, in a randomised controlled single blinded clinical trial. Primary Measures: Total opiate usage in the first 48 hours after surgery ;Secondary Objective: Poorly controlled analgesia is associated with prolongation of hospital stay and increased morbidity. The use of paravertebral nerve blocks, wound catheters and morphine PCA's (patient controlled analgesia) are well established approaches to post operative analgesia. We plan to show that both paravertebral and wound catheters will provide very satisfactory analgesia post operatively. Morphine is associated with sedation, nausea, vomiting and itch. We plan to show a statistically significant decrease in these side effects in the paravertebral and wound infiltration groups. We will also look at patient satisfaction;Primary end point(s): Total opiate usage in the first 48 hours after surgery;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: We aim to compare the analgesic efficacy of continuous paravertebral blockade and continuous wound infiltration with a control, for post operative pain in the first 48 post operative hours, following mastectomy and, in a randomised controlled single blinded clinical trial. Primary Measures: Total opiate usage in the first 48 hours after surgery ;Secondary Objective: Poorly controlled analgesia is associated with prolongation of hospital stay and increased morbidity. The use of paravertebral nerve blocks, wound catheters and morphine PCA's (patient controlled analgesia) are well established approaches to post operative analgesia. We plan to show that both paravertebral and wound catheters will provide very satisfactory analgesia post operatively. Morphine is associated with sedation, nausea, vomiting and itch. We plan to show a statistically significant decrease in these side effects in the paravertebral and wound infiltration groups. We will also look at patient satisfaction;Primary end point(s): Total opiate usage in the first 48 hours after surgery;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Severity of Postoperative Pain, [VAS and Categorical pain Scales] Sedation Postoperative nausea, vomiting and itch Patient Satisfaction ;Timepoint(s) of evaluation of this end point: 48 hours	—

Countries

Ireland

Contacts

Public ContactJohn McDonnell

Department of Anaesthesia

johngmcdonnell@gmail.com+35391544074

Outcome results

None listed

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