BreastcancerETCINCT03030677
Establishing Technique for PECS2 Catheter Insertion
A study testing Pectoralis II block & catheter without Lidocaine dissection, Pectoralis II block & catheter with Lidocaine dissection and catheter insertion in people with Breastcancer and Phyllodes Breast Tumor, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Breastcancer, Phyllodes Breast Tumor
- What is being tested?
- Pectoralis II block & catheter without Lidocaine dissection, Pectoralis II block & catheter with Lidocaine dissection and catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patient scheduled for simple mastectomy
- Accepted performing the block
Who cannot join
- Patients on anticogulants
- Chest wall infection
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence
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
Read the 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
- Conditions
- Breastcancer, Phyllodes Breast Tumor
- Being tested
- Pectoralis II block & catheter without Lidocaine dissection, Pectoralis II block & catheter with Lidocaine dissection, catheter insertion
- Keywords
- pecs block, breast surgery, ultrasound guidence
- Medical subject headings
- Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoralis II block & catheter without Lidocaine dissectionProcedure or surgery
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
Pectoralis II block & catheter with Lidocaine dissectionProcedure or surgery
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
catheter insertionOther
catheter insertion after Lidocaine dissection
| Study group | Role | What they receive |
|---|---|---|
| Interventional Without Dissectioin | Other | 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 Receives: Procedure: Pectoralis II block & catheter without Lidocaine dissection; Other: catheter insertion |
| Interventional With Dissectioin | Other | 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 Receives: Procedure: Pectoralis II block & catheter with Lidocaine dissection; Other: catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful catheter insertion
confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound
Measured: during time of performing the block
Secondary outcomes (2)
Number of attempts
Number of attempts needed for successful insertion
Measured: during time of performing the block
Duration needed for insertion
Duration needed for successful insertion
Measured: during time of performing the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Nov 2018
- Primary completion31 Aug 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mansour, Kasr El Aini Hospital
- Investigators
- Mohamed Ah Mansour, ass.prof, Principal investigator, Kasr Al Aini Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030677
- Sponsor's protocol ID
- MMSTD1Pecs2
- Acronym
- ETCI
- Status last verified
- Sep 2020
- First submitted
- 5 Jan 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence
- ClinicalTrials.gov ID
- NCT03030677
- Acronym / sponsor ID
- ETCI / MMSTD1Pecs2
- Conditions
- Breastcancer, Phyllodes Breast Tumor
- Keywords
- pecs block, breast surgery, ultrasound guidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Without Dissectioin | Other | Procedure: Pectoralis II block & catheter without Lidocaine dissection, Other: catheter insertionconfirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution |
| Interventional With Dissectioin | Other | Procedure: Pectoralis II block & catheter with Lidocaine dissection, Other: catheter insertionconfirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patient scheduled for simple mastectomy
- Accepted performing the block
Key exclusion criteria (3 listed)
- Patients on anticogulants
- Chest wall infection
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectoralis II block & catheter without Lidocaine dissectionB 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 | Procedure or surgery | Interventional Without Dissectioin |
| Pectoralis II block & catheter with Lidocaine dissectionB 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 | Procedure or surgery | Interventional With Dissectioin |
| catheter insertioncatheter insertion after Lidocaine dissection | Other | Interventional With Dissectioin, Interventional Without Dissectioin |
Primary outcome
successful catheter insertion
Time frame: during time of performing the block
confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound
2 secondary outcomes
Number of attempts
Time frame: during time of performing the block
Duration needed for insertion
Time frame: during time of performing the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ah Mansour, ass.prof principal investigator
Kasr Al Aini Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoralis II block & catheter without Lidocaine dissection, Pectoralis II block & catheter with Lidocaine dissection and catheter insertion in people with Breastcancer and Phyllodes Breast Tumor, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful catheter insertion (time frame: during time of performing the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.