Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547989

Enrollment

Registered

2007-10-23

Start date

2006-10-31

Completion date

2011-05-31

Last updated

2014-06-11

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

Conditions

Breast Cancer

Keywords

ASA class I and II

Brief summary

Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

Detailed description

Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m. Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia. A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.

Interventions

DRUGstandard anaesthesia (bupivacaine)

Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required

DRUGadditional pvb (ropivacaine) and elastomeric disposable infusion pump

Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.

DRUGadditional pvb (ropivacaine)

Patients in group 1 will receive PVB with ropivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Extended mamma surgery one-sided * ASA class I and II

Exclusion criteria

* All contra indications for local anaesthesia * Coagulation disorders * Infection * Allergic reactions

Design outcomes

Primary

Measure	Time frame
reduction of unplanned admissions and reduction of VAS score.	one week

Secondary

Measure	Time frame
to determine the safety and performance (efficacy) of the technique and the investigational product.	one week

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026