Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

NCT ID: NCT02035904

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Acute Pain; Chronic Pain; Wound Infusion; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Levobupivacaine

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

Group Type: EXPERIMENTAL

Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)

Intervention Type: DRUG

patient controlled infusion from the 2nd day after surgery

Levobupivacaine continuous infusion

Intervention Type: DRUG

Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients

intrawound infusion catheter

Intervention Type: DEVICE

placed by surgeon at the end surgery in all patients

morphine

Intervention Type: DRUG

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

Patrol

Intervention Type: DRUG

tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)

Saline

patient controlled infusion 5 ml bolus, lock out 2 hours

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

patient controlled infusion from the 2nd day after surgery

Levobupivacaine continuous infusion

Intervention Type: DRUG

Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients

intrawound infusion catheter

Intervention Type: DEVICE

placed by surgeon at the end surgery in all patients

morphine

Intervention Type: DRUG

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

Patrol

Intervention Type: DRUG

tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)

Interventions

Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)

patient controlled infusion from the 2nd day after surgery

Intervention Type: DRUG

saline

patient controlled infusion from the 2nd day after surgery

Intervention Type: DRUG

Levobupivacaine continuous infusion

Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients

Intervention Type: DRUG

intrawound infusion catheter

placed by surgeon at the end surgery in all patients

Intervention Type: DEVICE

morphine

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

Intervention Type: DRUG

Patrol

tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Massimo Allegri

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allegri Massimo, MD

Role: PRINCIPAL_INVESTIGATOR

Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy

Locations

Department of Anesthesia - Pain Therapy Service

Pavia, Pavia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Allegri Massimo, MD

Role: CONTACT

massimo.allegri@unipv.it

+390382502627

Facility Contacts

Allegri Massimo, MD

Role: primary

massimo.allegri@unipv.it

+390382502627

Other Identifiers

2011-006331-35

Identifier Type: -

Identifier Source: org_study_id