Regional Anesthesia for Breast Surgery

Not Applicable

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT03941223
• Lead Sponsor: Azienda USL Reggio Emilia - IRCCS

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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-05-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine requirement	1 day	Morphine self-administered by a patient controlled device

Secondary Outcome Measures

Name	Time	Method
Persistent Postsurgical pain (PPSP)	2 years	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	2 years	Incidence of cancer recurrence
postoperative pain	2 days	Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively

Trial Locations

Locations (1)

AUSL IRCCS Reggio Emilia; 🇮🇹 Reggio Emilia, Italy