Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by IRCCS Policlinico S. Matteo
Sponsor:
Information provided by (Responsible Party):
Massimo Allegri, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT02035904
First received: January 11, 2014
Last updated: January 13, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction in pain values at rest and movement in treatment group [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • incidence of drug-related side effects [ Time Frame: up to 14 days ] [ Designated as safety issue: Yes ]
    local anesthetic toxicity, opioid side effects

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

  • earlier upper limb rehabilitation [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    physiatric evaluations

  • earlier return to social activities and good quality of life [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    validated SF-36 questionnaire

  • different chronic pain incidence [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    phone interview at 1 and 3 months


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Massimo Allegri, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02035904     History of Changes
Other Study ID Numbers: 2011-006331-35
Study First Received: January 11, 2014
Last Updated: January 13, 2014
Health Authority: Italy: Ethics Committee

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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on October 16, 2014