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

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

reduction of unplanned admissions and reduction of VAS score.

Outcome Time Frame:

one week

Safety Issue:


Principal Investigator

Esther Bouman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC 05-105.5



Start Date:

October 2006

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • ASA class I and II
  • Breast Neoplasms