Chronic Pain Clinical Trial
The aim of the study is to evaluate efficacy and safety of long term (14 days) wound
infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with
immediate breast reconstruction: this is a double blind, randomized, parallel group study.
The study moves from the concept that nociceptive stimulus last further than 48 hours after
surgical intervention: long term analgesia is necessary to provide a real benefit to the
patient and provide central sensitization. Intralesional catheter is placed at the end of
surgery. In the first 24 postoperative hours we provide continuous wound infusion with
levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4.
From the second postoperative day morphine PCA is removed and patients are randomized to
receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours,
with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination
(Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after
36 hours of non-use.
Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed;
pain physicians also care about any catheter-related or drug-related side effect,
registering number of total boluses. Patients are provided with a home diary for pain scores
to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3
month is performed to investigate pain chronicization.
Surgical evaluation is provided, also to establish any catheter-related infective or healing
complication.
Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure
rehabilitation process.
A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to
understand differences in return to a normal quality of life and to social activities
between the two groups.
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