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

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: additional pvb (ropivacaine); Drug: standard anaesthesia (bupivacaine); Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump

Study type: Interventional

Funder types: Other

Identifiers

NCT00547989

MEC 05-105.5

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

1

Active Comparator group

Description:

control

Treatment:

Drug: standard anaesthesia (bupivacaine)

2

Experimental group

Description:

PVB with ropivacaine and postoperative pump 5ml/h

Treatment:

Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump

Experimental 1

Experimental group

Description:

PVB with ropivacaine, 10 patients included but not analysed

Treatment:

Drug: additional pvb (ropivacaine)