The effect of a paravertebral block on postoperative pain in patients with breast cancer.

Pain relief after surgery in patients with breast cancer is one of the basic
factors that contribute to adequate treatment and rehabilitation of patients.
Several studies show that breast surgery can be associated with postoperative
pain, nausea, vomiting and, finally, chronic pain.

There are indications that a paravertebral block provides a more adequate pain
relief, less nausea and less vomiting after surgery. In addition, the technique
of administering a paravertebral block is relatively easy to learn, and has
fewer side effects than other techniques.

However, there is still no clear directive on the use of locoregional
anesthetic techniques in breast surgery and the role of morphine use
postoperatively.

We want to investigate wether a para-vertebral block contributes to a reduced
postoperative pain and morphine consumption in patients with breast cancer
after a unilateral mastectomy or lumpectomy. By doing this investigation we
hope to clarify, wether a paravertebral block technique can help to improve
postoperative outcome in patients undergoing breast surgery.

The main question is: Does addition of a paravertebral block to general
anesthesia in patients with breast cancer who will undergo an unilateral
mastectomy or lumpectomy give decreased postoperative pain and thereby a
reduction in consumption of analgesic medication compared with patients who
received only perioperative analgesia intravenously?

Secondary:
Does addition of a paravertebral block to general anesthesia in patients with
breast cancer who will undergo breast surgery give less nausea and vomiting
compared with patients who receive only intravenous perioperative analgesia?

Does addition of a paravertebral block to general anesthesia in patients with
breast cancer who will undergo breast surgery give a reduction in chronic pain
compared with patients who receive intravenous perioperative analgesia?

All patients will undergo surgery in the elective setting. Before
randomization, all patients will be stratified by the type of operation:
Unilateral mastectomy or lumpetctomy with or without SNB and / or unilateral
mastectomy with or without axillary node dissection. The patients will be
randomized into two equal groups using sealed envelopes.

Preoperatively, all patients will receive 1000 mg Paracetamol. Both groups will
receive general anesthesia using Ultiva (Ultiva, GlaxoSmithKline BV, RVG number
20601) and Propofol (Propofol-Lipuro, B. Braun Melsungen AG, RVG number: 24720)

Patients in group 1 will receive on the holding a paravertebral block. There
will be 15-20ml Ropivacaine (Ropivacaine HCl Fresenius Kabi, RVG number 104941)
0.75% given via the paravertebral catheter.
Post-operatively patients will get 3-6ml/hour Ropivacaine via the paravertebral
block. The catheter will be removed +/- 48 hours post-operatively.

Patients in group 2 will only receive general anesthesia using Ultiva and
Propofol and won't get a paravertebral block.

All patients will get analgesic basic medication post-operatively, 4dd 1000mg
Paracetamol and Naproxen 500mg 2dd given. In addition, both groups receive
after the operation a PCA pump with Dipidolor. Dipidolor 1.5 mg per bolus will
be given with a lockout of 6 minutes. Alternative opioids can be given in
patients who don't tolerate Dipidolor.

Paravertebral block, There will be 15-20ml Ropivacaine (Ropivacaine HCl
Fresenius Kabi, RVG number 104941) 0.75% given via the paravertebral catheter.

There is a risk for a pneumothorax and epidural spread. However this risk is
0.5%. (Schnabel e.a. Efficacy and safety of paravertebral blocks in breast
surgery: a meta-analysis of randomized controlled trials.Br J Anaesth. 2010)
The paravertebral techniques that will be used in this study, have already been
practised frequently in the Jeroen Bosch Ziekenhuis. A paravertebal block has
been offered to patiënts. Therefore, there is a slight additional load and/or
risk.