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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Regional Anesthesia for Breast Surgery

Clinicaltrials.gov identifier NCT03941223

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted June 6, 2019

Study Description

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.

  • Condition or Disease:Breast Cancer
  • Intervention/Treatment: Procedure: PECSII and paravertebral blocks
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Prospective, Randomized Comparison Between Paravertebral and Pectoral Nerve Block on Postoperative Pain, Persistent Post Surgical Pain and Cancer Recurrence After Mastectomy
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: June 2022
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Morphine requirement [ Time Frame: 1 day ]
    Morphine self-administered by a patient controlled device
  • Secondary Outcome Measures: 1. postoperative pain [ Time Frame: 2 days ]
    Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively
  • 2. Persistent Postsurgical pain (PPSP) [ Time Frame: 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
  • 3. cancer recurrence [ Time Frame: 2 years ]
    Incidence of cancer recurrence
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: gianluca cappelleri, MD +3905222961 gianluca.cappelleri@ausl.re.it

Contact: gianluca cappelleri

Locations

Italy
AUSL IRCCS Reggio Emilia
Reggio Emilia

Sponsors and Collaborators

Arcispedale Santa Maria Nuova-IRCCS

Investigators

Principal Investigator: gianluca cappelleri, MD AUSL IRCCS Reggio Emilia, Italy

More Information
  • Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
  • ClinicalTrials.gov Identifier: NCT03941223 History of Changes
  • Other Study ID Numbers: Breastblock
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: June 6, 2019
  • Last Verified: June 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Arcispedale Santa Maria Nuova-IRCCS: breast cancer, regional anesthesia, cancer recurrence
  • Additional relevant MeSH terms: Breast Neoplasms