Acute Pain, Chronic Pain, Mastectomy, Wound Infusion
Conditions
Brief 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.
Interventions
DRUGLevobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
patient controlled infusion from the 2nd day after surgery
DRUGsaline
patient controlled infusion from the 2nd day after surgery
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
DEVICEintrawound infusion catheter
placed by surgeon at the end surgery in all patients
DRUGmorphine
PCA with morphine: 0,5 mg/ml bolus 1 mg lock-out 5 min max 20 mg in 4 hs - for the first 24 hs as rescue analgesia
DRUGPatrol
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* F; age 18 to 70 * American Society of Anesthesiologists (ASA) I e II; * breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection; * immediate sub-pectoral prosthetic reconstruction; * signed informed consent.
Exclusion criteria
* preexisting pectoral, axillar, thoracic homolateral pain * habitual opioid consumption; * drug-alcoholics addiction ; * ICU postoperative recovery; * kidney failure (creatinin \> 2 g/dl, creatinin \<clearance 30 ml/h) and/or hepatic failure (cholinesterase \< 2000 UI); * cardiac arrhythmias o; * Epilepsy; * Psychiatric, cognitive disorders, mental retardation; * Coagulopathies (INR \> 2, activated partial thromboplastin time - aPTT\>44 sec); * platelet count less than 100.000/mm3; * BMI \> 30; * Allergies to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy | from day 2 to 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of drug-related side effects | up to 14 days | local anesthetic toxicity, opioid side effects |
| incidence of catheter-related surgical complications | up to 1 month | infections, healing retardation |
| reduction in pain values at rest and movement in treatment group | 14 days | — |
| earlier return to social activities and good quality of life | up to 1 month | validated SF-36 questionnaire |
| different chronic pain incidence | up to 3 months | phone interview at 1 and 3 months |
| earlier upper limb rehabilitation | up to 1 month | physiatric evaluations |
Countries
Italy
Contacts
Primary ContactAllegri Massimo, MD
Outcome results
None listed