Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

IRCCS Policlinico S. Matteo

Status and phase: Unknown; Phase 4

Conditions: Mastectomy; Wound Infusion; Chronic Pain; Acute Pain

Treatments: Drug: saline; Drug: morphine; Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia); Device: intrawound infusion catheter; Drug: Patrol; Drug: Levobupivacaine continuous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02035904

2011-006331-35

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Levobupivacaine

Experimental group

Description:

Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours

Treatment:

Device: intrawound infusion catheter

Drug: Levobupivacaine continuous infusion

Drug: morphine

Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)

Drug: Patrol

Saline

Placebo Comparator group

Description:

patient controlled infusion 5 ml bolus, lock out 2 hours

Treatment:

Device: intrawound infusion catheter

Drug: Levobupivacaine continuous infusion

Drug: morphine

Drug: saline

Drug: Patrol