Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
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.