Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

NCT02035904 | Unknown Phase 4 DMC

• 1 other identifier: 2011-006331-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy

  from day 2 to 14

Secondary Outcomes (6)

• reduction in pain values at rest and movement in treatment group

  14 days

• incidence of drug-related side effects

  up to 14 days

• incidence of catheter-related surgical complications

  up to 1 month

• earlier upper limb rehabilitation

  up to 1 month

• earlier return to social activities and good quality of life

  up to 1 month

Study Arms (2)

Levobupivacaine

EXPERIMENTAL

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

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

Saline

PLACEBO COMPARATOR

patient controlled infusion 5 ml bolus, lock out 2 hours

Drug: saline; Drug: Levobupivacaine continuous infusion; Device: intrawound infusion catheter; Drug: morphine; Drug: Patrol

Interventions

Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia) DRUG

patient controlled infusion from the 2nd day after surgery

Levobupivacaine

saline DRUG

patient controlled infusion from the 2nd day after surgery

Saline

Levobupivacaine continuous infusion DRUG

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

Levobupivacaine; Saline

intrawound infusion catheter DEVICE

placed by surgeon at the end surgery in all patients

Levobupivacaine; Saline

morphine 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

Levobupivacaine; Saline

Patrol DRUG

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

Levobupivacaine; Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Department of Anesthesia - Pain Therapy Service

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Sodium Chloride; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Allegri Massimo, MD

  Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allegri Massimo, MD

CONTACT

+390382502627; massimo.allegri@unipv.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

IT (1)