Regional Anesthesia for Breast Surgery

NCT ID: NCT03941223

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

PECSII and paravertebral blocks

Intervention Type PROCEDURE

Regional anesthesia for mastectomy outcomes

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)

Group Type ACTIVE_COMPARATOR

PECSII and paravertebral blocks

Intervention Type PROCEDURE

Regional anesthesia for mastectomy outcomes

Interventions

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PECSII and paravertebral blocks

Regional anesthesia for mastectomy outcomes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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gianluca cappelleri, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL IRCCS Reggio Emilia, Italy

Locations

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AUSL IRCCS Reggio Emilia

Reggio Emilia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Breastblock

Identifier Type: -

Identifier Source: org_study_id

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