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Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

This study is currently recruiting participants.
Verified March 2017 by Massimo Allegri, IRCCS Policlinico S. Matteo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035904
First Posted: January 14, 2014
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Massimo Allegri, IRCCS Policlinico S. Matteo
  Purpose

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.


Condition Intervention Phase
Acute Pain Chronic Pain Wound Infusion Mastectomy Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia) Drug: saline Drug: Levobupivacaine continuous infusion Device: intrawound infusion catheter Drug: morphine Drug: Patrol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Massimo Allegri, IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy [ Time Frame: from day 2 to 14 ]

Secondary Outcome Measures:
  • reduction in pain values at rest and movement in treatment group [ Time Frame: 14 days ]
  • incidence of drug-related side effects [ Time Frame: up to 14 days ]
    local anesthetic toxicity, opioid side effects

  • incidence of catheter-related surgical complications [ Time Frame: up to 1 month ]
    infections, healing retardation

  • earlier upper limb rehabilitation [ Time Frame: up to 1 month ]
    physiatric evaluations

  • earlier return to social activities and good quality of life [ Time Frame: up to 1 month ]
    validated SF-36 questionnaire

  • different chronic pain incidence [ Time Frame: up to 3 months ]
    phone interview at 1 and 3 months


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
patient controlled infusion from the 2nd day after surgery
Drug: Levobupivacaine continuous infusion
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
Device: intrawound infusion catheter
placed by surgeon at the end surgery in all patients
Drug: 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
Drug: Patrol
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)
Placebo Comparator: Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
Drug: saline
patient controlled infusion from the 2nd day after surgery
Drug: Levobupivacaine continuous infusion
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
Device: intrawound infusion catheter
placed by surgeon at the end surgery in all patients
Drug: 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
Drug: Patrol
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035904


Contacts
Contact: Allegri Massimo, MD +390382502627 massimo.allegri@unipv.it

Locations
Italy
Department of Anesthesia - Pain Therapy Service Recruiting
Pavia, Italy, 27100
Contact: Allegri Massimo, MD    +390382502627    massimo.allegri@unipv.it   
Sub-Investigator: Bugada Dario, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Allegri Massimo, MD Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
  More Information

Additional Information:
Responsible Party: Massimo Allegri, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02035904     History of Changes
Other Study ID Numbers: 2011-006331-35
First Submitted: January 11, 2014
First Posted: January 14, 2014
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Levobupivacaine
Bupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics