Trial Information

Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery

This is a prospective, double-blind, randomized, single centre study Adult ASA I - II
patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph
node dissection are included in the study. Patients receiving opioid or any other analgesic
treatment for chronic pain before surgery, patients with known allergy to local
anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded.

Patients are allocated randomly into two groups on the morning of surgery, using random
numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for
induction, and sevoflurane In the treated group infiltration is performed with a ropivacaine
7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two
groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane
and nitrous oxide for maintenance. Twenty milliliters of the allocated solution are used at
the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the
level of the breast and axilla surgical incision. Postoperatively, 8 tablets of paracetamol
500 mg were let at patient' disposal every 24 hours for 3 days. If pain control is not
adequate patients receive 5 mg of subcutaneous morphine as a rescue.

Pain intensity is measured on a visual analogue scale graded from 0 to 100. Measurements are
performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after
the end of surgery. The value of maximum abduction angle is noted.

To evaluate quality of life patients are asked to score on a 4 points scale graded from 0
(the worst) to 3 (the best) the following items: sleep - fatigue - global activity -
relationship with relatives - state of mood. A global score is attributed to each patient
as the sum of categorical scores. Evaluation is performed at 24, 48 and 72 hour after the
end of surgery.

Patients are evaluated at two month for residual pain at rest and on movement using a visual
analogue scale and for quality of life as previously defined.