Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03941223

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Azienda USL Reggio Emilia - IRCCS · Other Government
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPECSII and paravertebral blocksRegional anesthesia for mastectomy outcomes

Timeline

Start date
2019-05-29
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2019-05-07
Last updated
2025-06-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03941223. Inclusion in this directory is not an endorsement.