Regional Anesthesia for Breast Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: PECSII and paravertebral blocks

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: gianluca cappelleri, MD; Phone Number: +3905222961; Email: gianluca.cappelleri@ausl.re.it
• Study Contact Backup: Name: gianluca cappelleri

Study Locations

• Italy
  • Reggio Emilia, Italy, 42120
    • Recruiting
    • AUSL IRCCS Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pectoral PECS II block; 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	Procedure: PECSII and paravertebral blocks; Regional anesthesia for mastectomy outcomes
Active Comparator: Paravertebral nerve block; Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)	Procedure: PECSII and paravertebral blocks; Regional anesthesia for mastectomy outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine requirement	Morphine self-administered by a patient controlled device	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively	2 days
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	2 years
cancer recurrence	Incidence of cancer recurrence	2 years

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: gianluca cappelleri, MD, AUSL IRCCS Reggio Emilia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer, regional anesthesia, cancer recurrence
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Breastblock

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No