Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03941223
Other study ID # Breastblock
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date June 2022

Study information

Verified date June 2019
Source Arcispedale Santa Maria Nuova-IRCCS
Contact gianluca cappelleri, MD
Phone +3905222961
Email gianluca.cappelleri@ausl.re.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 2022
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PECSII and paravertebral blocks
Regional anesthesia for mastectomy outcomes

Locations

Country Name City State
Italy AUSL IRCCS Reggio Emilia Reggio Emilia

Sponsors (1)

Lead Sponsor Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine requirement Morphine self-administered by a patient controlled device 1 day
Secondary postoperative pain Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively 2 days
Secondary Persistent Postsurgical pain (PPSP) Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up 2 years
Secondary cancer recurrence Incidence of cancer recurrence 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2