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Regional Anesthesia for Breast Surgery

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ClinicalTrials.gov Identifier: NCT03941223
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, Arcispedale Santa Maria Nuova-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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: PECSII and paravertebral blocks Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 29, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941223


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

Locations
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Italy
AUSL IRCCS Reggio Emilia Recruiting
Reggio Emilia, Italy, 42120
Contact: gianluca cappelleri, MD       gianluca.cappelleri@ausl.re.it   
Contact: gianluca cappelleri, MD         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
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Principal Investigator: gianluca cappelleri, MD AUSL IRCCS Reggio Emilia, Italy
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Responsible Party: Gianluca Cappelleri, principal investigator, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT03941223    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianluca Cappelleri, Arcispedale Santa Maria Nuova-IRCCS:
breast cancer, regional anesthesia, cancer recurrence
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases