Establishing Technique for PECS2 Catheter Insertion (ETCI)
Primary Purpose
Breastcancer, Phyllodes Breast Tumor
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pectoralis II block & catheter without Lidocaine dissection
Pectoralis II block & catheter with Lidocaine dissection
catheter insertion
Sponsored by
About this trial
This is an interventional supportive care trial for Breastcancer focused on measuring pecs block, breast surgery, ultrasound guidence
Eligibility Criteria
Inclusion Criteria:
- Female patient scheduled for simple mastectomy
- Accepted performing the block
Exclusion Criteria:
- Patients on anticogulants
- Chest wall infection
- Patient refusal
Sites / Locations
- Kasr Alaini Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Interventional Without Dissectioin
Interventional With Dissectioin
Arm Description
confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution
confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution
Outcomes
Primary Outcome Measures
successful catheter insertion
confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound
Secondary Outcome Measures
Number of attempts
Number of attempts needed for successful insertion
Duration needed for insertion
Duration needed for successful insertion
Full Information
NCT ID
NCT03030677
First Posted
January 5, 2017
Last Updated
September 7, 2020
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03030677
Brief Title
Establishing Technique for PECS2 Catheter Insertion
Acronym
ETCI
Official Title
Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are trying to establish an easy technique for insertion of a catheter for continuous infusion while performing pectoral type 2 (serratus) block, as a post operative pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence
Detailed Description
As the space between the pectoralis minor and the serratus anterior is a fashial plane with a connective tissue occupying. we are trying to demonstrate a simple technique for inserting a catheter within that fashial plane and making sure of the catheter position, to ensure post operative analgesia for cases performing simple mastectomy.
Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block technique for chest wall procedures.
We are trying to maximizing the benefit of the block with a catheter insertion to use it for continuous infusion of bupivacaine for controlling post operative pain in cases performing simple mastectomy procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastcancer, Phyllodes Breast Tumor
Keywords
pecs block, breast surgery, ultrasound guidence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Without Dissectioin
Arm Type
Other
Arm Description
confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution
Arm Title
Interventional With Dissectioin
Arm Type
Other
Arm Description
confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution
Intervention Type
Procedure
Intervention Name(s)
Pectoralis II block & catheter without Lidocaine dissection
Intervention Description
B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
Intervention Type
Procedure
Intervention Name(s)
Pectoralis II block & catheter with Lidocaine dissection
Intervention Description
B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
Intervention Type
Other
Intervention Name(s)
catheter insertion
Intervention Description
catheter insertion after Lidocaine dissection
Primary Outcome Measure Information:
Title
successful catheter insertion
Description
confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound
Time Frame
during time of performing the block
Secondary Outcome Measure Information:
Title
Number of attempts
Description
Number of attempts needed for successful insertion
Time Frame
during time of performing the block
Title
Duration needed for insertion
Description
Duration needed for successful insertion
Time Frame
during time of performing the block
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patient scheduled for simple mastectomy
Accepted performing the block
Exclusion Criteria:
Patients on anticogulants
Chest wall infection
Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Ah Mansour, ass.prof
Organizational Affiliation
Kasr Al Aini Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alaini Hospitals
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/27871558
Description
Related Info
Learn more about this trial
Establishing Technique for PECS2 Catheter Insertion
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