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Regional Anesthesia for Breast Surgery

A

Azienda USL Reggio Emilia - IRCCS

Status

Withdrawn

Conditions

Breast Cancer

Treatments

Procedure: PECSII and paravertebral blocks

Study type

Interventional

Funder types

Other

Identifiers

NCT03941223
Breastblock

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

pectoral PECS II block
Experimental group
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
Treatment:
Procedure: PECSII and paravertebral blocks
Paravertebral nerve block
Active Comparator group
Description:
Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)
Treatment:
Procedure: PECSII and paravertebral blocks

Trial contacts and locations

1

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Central trial contact

gianluca cappelleri, MD; gianluca cappelleri

Data sourced from clinicaltrials.gov

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