Continuous Serrates Plane Block in Axillary Dissection
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous serratus plane block
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring regional anesthesia
Eligibility Criteria
Inclusion Criteria:
- age > 18
- breast surgery
- informed consent
Exclusion Criteria:
- ASA >3
- allergy to local anesthetic
- opioid administration in the last month
- patient refusal
Sites / Locations
- Ausl-Irccs Reggio EmiliaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
serratus catheter
standard treatment
Arm Description
Continuous serratus plane block: Ropivacaine 0.2% infusion through a multiple hole catheter (C-Cat Cimpax Denmark)at a fixed dose of 12 ml/h and a multimodal analgesia with acetaminophen and a PCA of morphine
Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine
Outcomes
Primary Outcome Measures
Morphine consumption
A 70% reduction in morphine consumption in the continuous serratus plane block over control
Secondary Outcome Measures
persistent post-surgical pain: numerical rating scale
a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4
Full Information
NCT ID
NCT03992859
First Posted
November 14, 2018
Last Updated
June 19, 2019
Sponsor
Arcispedale Santa Maria Nuova-IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT03992859
Brief Title
Continuous Serrates Plane Block in Axillary Dissection
Official Title
Continuous Serratus Plane Block Added to PECS II vs PECS II Alone for Post Operative Analgesia After Axillary Dissection in Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Anticipated)
Study Completion Date
June 13, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arcispedale Santa Maria Nuova-IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.
Detailed Description
84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
regional anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
serratus catheter
Arm Type
Experimental
Arm Description
Continuous serratus plane block: Ropivacaine 0.2% infusion through a multiple hole catheter (C-Cat Cimpax Denmark)at a fixed dose of 12 ml/h and a multimodal analgesia with acetaminophen and a PCA of morphine
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine
Intervention Type
Procedure
Intervention Name(s)
Continuous serratus plane block
Intervention Description
Peripheral nerve catheter placed by the surgeon at the end of surgery
Primary Outcome Measure Information:
Title
Morphine consumption
Description
A 70% reduction in morphine consumption in the continuous serratus plane block over control
Time Frame
12-48 hours
Secondary Outcome Measure Information:
Title
persistent post-surgical pain: numerical rating scale
Description
a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4
Time Frame
3-6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18
breast surgery
informed consent
Exclusion Criteria:
ASA >3
allergy to local anesthetic
opioid administration in the last month
patient refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico bizzarri
Phone
3478351913
Email
federicotommaso.bizzarri@ausl.re.it
First Name & Middle Initial & Last Name or Official Title & Degree
Federico bizzarri
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico bizzarri, MD
Organizational Affiliation
Arcispedale Santa Maria Nuova-IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ausl-Irccs Reggio Emilia
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42120
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
federico bizzarri, MD
Email
federicotommaso.bizzarri@ausl.re.it
12. IPD Sharing Statement
Learn more about this trial
Continuous Serrates Plane Block in Axillary Dissection
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