Clinical trial NCT02035904: Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pain
Chronic Pain
Wound Infusion
Mastectomy
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
timeFrame: from day 2 to 14
Secondary outcomes:
measure: reduction in pain values at rest and movement in treatment group
timeFrame: 14 days
measure: incidence of drug-related side effects
timeFrame: up to 14 days
measure: incidence of catheter-related surgical complications
timeFrame: up to 1 month
measure: earlier upper limb rehabilitation
timeFrame: up to 1 month
measure: earlier return to social activities and good quality of life
timeFrame: up to 1 month
measure: different chronic pain incidence
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Department of Anesthesia - Pain Therapy Service
Study officials:
affiliation: Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
name: Allegri Massimo, MD
role: PRINCIPAL_INVESTIGATOR
References: