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Regional Anesthesia for Breast Surgery

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

PECSII and paravertebral blocks

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, regional anesthesia, cancer recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients scheduled for radical mastectomy for cancer.
age > 18 y-o
Written informed consent

Exclusion Criteria:

Bilateral surgery
Opioids user
BMI > 35
Postoperative Intensive care

Sites / Locations

AUSL IRCCS Reggio EmiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pectoral PECS II block

Paravertebral nerve block

Arm Description

Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml

Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)

Outcomes

Primary Outcome Measures

Morphine requirement

Morphine self-administered by a patient controlled device

Secondary Outcome Measures

postoperative pain

Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively

Persistent Postsurgical pain (PPSP)

Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up

cancer recurrence

Incidence of cancer recurrence

Full Information

NCT ID

NCT03941223

First Posted

May 6, 2019

Last Updated

June 5, 2019

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT03941223

Brief Title

Regional Anesthesia for Breast Surgery

Official Title

A Prospective, Randomized Comparison Between Paravertebral and Pectoral Nerve Block on Postoperative Pain, Persistent Post Surgical Pain and Cancer Recurrence After Mastectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 29, 2019 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arcispedale Santa Maria Nuova-IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Detailed Description

Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining. Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered. Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h. Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, regional anesthesia, cancer recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pectoral PECS II block

Arm Type

Experimental

Arm Description

Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml

Arm Title

Paravertebral nerve block

Arm Type

Active Comparator

Arm Description

Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)

Intervention Type

Procedure

Intervention Name(s)

PECSII and paravertebral blocks

Intervention Description

Regional anesthesia for mastectomy outcomes

Primary Outcome Measure Information:

Title

Morphine requirement

Description

Morphine self-administered by a patient controlled device

Time Frame

1 day

Secondary Outcome Measure Information:

Title

postoperative pain

Description

Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively

Time Frame

2 days

Title

Persistent Postsurgical pain (PPSP)

Description

Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up

Time Frame

2 years

Title

cancer recurrence

Description

Incidence of cancer recurrence

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled for radical mastectomy for cancer. age > 18 y-o Written informed consent Exclusion Criteria: Bilateral surgery Opioids user BMI > 35 Postoperative Intensive care

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

gianluca cappelleri, MD

Phone

+3905222961

gianluca.cappelleri@ausl.re.it

First Name & Middle Initial & Last Name or Official Title & Degree

gianluca cappelleri

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

gianluca cappelleri, MD

Organizational Affiliation

AUSL IRCCS Reggio Emilia, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

AUSL IRCCS Reggio Emilia

City

Reggio Emilia

ZIP/Postal Code

42120

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

gianluca cappelleri, MD

gianluca.cappelleri@ausl.re.it

First Name & Middle Initial & Last Name & Degree

gianluca cappelleri, MD

12. IPD Sharing Statement

Plan to Share IPD

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Regional Anesthesia for Breast Surgery

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