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Trial registered on ANZCTR


Registration number
ACTRN12610000208000
Ethics application status
Approved
Date submitted
16/01/2010
Date registered
12/03/2010
Date last updated
12/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
T2-T6 Ultrasound guided Intercostal blocks versus General anaesthesia in quadrantectomies for perioperative and chronic pain management
Scientific title
T2-T6 Ultrasound guided Intercostal blocks versus General anaesthesia in quadrantectomies for perioperative and chronic pain management in women with breast cancer.
Secondary ID [1] 1416 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We study the possibility that regional anaesthesia in breast surgery can reduce neuropathic long term pain, as a preemptive analgesia. Patients undergoing quadrantectomies without axillary dissection. 256562 0
We study the possibility that regional anaesthesia in breast surgery can reduce postoperative pain, with a reduction of use of tramadol. Patients undergoing quadrantectomies without axillary dissection. 256680 0
We study the possibility that regional anaesthesia can reduce hospitalization, operatory room occupation and costs. Patients undergoing quadrantectomies without axillary dissection. 256681 0
Condition category
Condition code
Anaesthesiology 256732 256732 0 0
Pain management
Anaesthesiology 256837 256837 0 0
Other anaesthesiology
Cancer 256984 256984 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Regional anaesthesia. T2-T6 ultrasound guided intercostal blocks for quadrantectomies. The techique lasts a few minutes (max 3) and consists in infiltrating under ultrasound guidance the intercostal nerves from T2 to T6 with 3ml of ropivacaine 7.5mg/ml for each space. The technique is performed just once, before the intervention and non other treatment is required.
Intervention code [1] 255830 0
Treatment: Other
Comparator / control treatment
General anaesthesia. Duration: 30 minutes approximately, depending on the duration of the surgery. We perform a standard total intraveous general anaesthesia (TIVA) with propofol and remifentanyl continuous infusion. We position a laryngeal mask after induction with propofol 2mg/kg, Fentanyl 0.1mg and cisatracurium 0.1mg/kg.
Control group
Active

Outcomes
Primary outcome [1] 257614 0
VAS (visual analogic score) pain score 24 hours and then 2 years after intervention.
Timepoint [1] 257614 0
24 hours and then 2 years after the last quadrantectomy.
Primary outcome [2] 257705 0
Hospitalization and operatory room occupation. The hospitalization depends on clinical conditions and complications occurred, reported in medical records.
Timepoint [2] 257705 0
End 2 years after the beginning of the study.
Secondary outcome [1] 262887 0
Evaluation of the therapy and its impact on the patient's life. Evaluation based on questionnaires.
Timepoint [1] 262887 0
End 2 years aftyer the last quadrantectomy.
Secondary outcome [2] 263050 0
Evaluation of anthalgic therapy (tramadol) in the 24h following the intervention. Evaluation based on medical records.
Timepoint [2] 263050 0
End 2 years after the beginning of the study.
Secondary outcome [3] 263051 0
Evaluation of costs for the hospital and overall management: operatory room occupation, hours of hospitalization. Evaluation based on medical records.
Timepoint [3] 263051 0
End 2 years after the beginning of the study.

Eligibility
Key inclusion criteria
Classification American Society of Anaesthesiologists (ASA) 1-2-3.
Patients with breaast cancer scheduled for quadrantectomy without axillary dissection.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Classification American Society of Anaesthesiologists (ASA) 4.
Coagulation pathology.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2409 0
Italy
State/province [1] 2409 0

Funding & Sponsors
Funding source category [1] 256322 0
Hospital
Name [1] 256322 0
ASL2 Savonese PO S.Corona
Country [1] 256322 0
Italy
Primary sponsor type
Individual
Name
Mazza Andrea
Address
via XXV Aprile 128
17027 Pietra Ligure SV
Country
Italy
Secondary sponsor category [1] 251640 0
Hospital
Name [1] 251640 0
ASL2 Savonese PO S.Corona
Address [1] 251640 0
via XXV Aprile 128
17027 Pietra Ligure SV
Country [1] 251640 0
Italy
Other collaborator category [1] 1036 0
University
Name [1] 1036 0
Centro Trials IST
Address [1] 1036 0
IST Istituto Tumori Genova
Centro Trials
Largo Rosanna Benzi, 10 - 16132 GENOVA - ITALY
Country [1] 1036 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study is designed to decide if a regional anaesthesia for quadrantectomies is better than a general anaesthesia (the standard treatment). Pain and organization are the main outcomes. This new technique offers the possibility to reduce complications in patients with cardiovascular and lung comorbidities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30712 0
Address 30712 0
Country 30712 0
Phone 30712 0
Fax 30712 0
Email 30712 0
Contact person for public queries
Name 13959 0
Andrea Mazza
Address 13959 0
Ospedale Santa Corona
via XXV Aprile 128
17027 Pietra Ligure SV
Country 13959 0
Italy
Phone 13959 0
00393405954159
Fax 13959 0
Email 13959 0
[email protected]
Contact person for scientific queries
Name 4887 0
Andrea Mazza
Address 4887 0
Ospedale Santa Corona
via XXV Aprile 128
17027 Pietra Ligure SV
Country 4887 0
Italy
Phone 4887 0
00393405954159
Fax 4887 0
Email 4887 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.