- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035904
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Allegri Massimo, MD
- Phone Number: +390382502627
- Email: massimo.allegri@unipv.it
Study Locations
-
-
-
Pavia, Italy, 27100
- Recruiting
- Department of Anesthesia - Pain Therapy Service
-
Contact:
- Allegri Massimo, MD
- Phone Number: +390382502627
- Email: massimo.allegri@unipv.it
-
Sub-Investigator:
- Bugada Dario, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
|
patient controlled infusion from the 2nd day after surgery
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
placed by surgeon at the end surgery in all patients
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
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
|
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
placed by surgeon at the end surgery in all patients
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
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)
patient controlled infusion from the 2nd day after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
Time Frame: from day 2 to 14
|
from day 2 to 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduction in pain values at rest and movement in treatment group
Time Frame: 14 days
|
14 days
|
|
incidence of drug-related side effects
Time Frame: up to 14 days
|
local anesthetic toxicity, opioid side effects
|
up to 14 days
|
incidence of catheter-related surgical complications
Time Frame: up to 1 month
|
infections, healing retardation
|
up to 1 month
|
earlier upper limb rehabilitation
Time Frame: up to 1 month
|
physiatric evaluations
|
up to 1 month
|
earlier return to social activities and good quality of life
Time Frame: up to 1 month
|
validated SF-36 questionnaire
|
up to 1 month
|
different chronic pain incidence
Time Frame: up to 3 months
|
phone interview at 1 and 3 months
|
up to 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allegri Massimo, MD, Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-006331-35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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