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

January 11, 2014
January 13, 2014
January 2013
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02035904 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Acute Pain
  • Chronic Pain
  • Wound Infusion
  • Mastectomy
  • Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
    patient controlled infusion from the 2nd day after surgery
  • 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)
  • Experimental: Levobupivacaine
    Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
    Interventions:
    • Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
    • Drug: Levobupivacaine continuous infusion
    • Device: intrawound infusion catheter
    • Drug: morphine
    • Drug: Patrol
  • Placebo Comparator: Saline
    patient controlled infusion 5 ml bolus, lock out 2 hours
    Interventions:
    • Drug: saline
    • Drug: Levobupivacaine continuous infusion
    • Device: intrawound infusion catheter
    • Drug: morphine
    • Drug: Patrol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact: Allegri Massimo, MD +390382502627 massimo.allegri@unipv.it
Italy
 
NCT02035904
2011-006331-35
Yes
Massimo Allegri, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Principal Investigator: Allegri Massimo, MD Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
IRCCS Policlinico S. Matteo
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP