Breast CancerPhase 3NCT04239716
Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection
A Phase 3 study testing regional anesthesia in people with Breast Cancer, run by Tanta University at 1 site in Egypt.
Trial summary
local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and… Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- regional anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Oct 2022
- Phase
- Phase 3
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 40-85 years old
- American Society of Anesthesiologists' physical status III and IV
- Planned for modified radical mastectomy with axillary lymph node dissection
Who cannot join
- Patient refusal
- Neurological or psychiatric disorders
- Local infection at injection site
- Spine or chest wall deformity
- Allergy or any contraindication to any of the study drugs
- Opioid or alcoholic addiction
- Chronic pain of any cause
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Combined Ultrasound Guided Interscalene Brachial Plexus Block and Erector Spinae Plane Block for Anesthesia in Modified Radical Mastectomy With Axillary Lymph Node Dissection: Pilot Study
local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.
Read the detailed description
inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.
- Conditions
- Breast Cancer
- Being tested
- regional anesthesia
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaOther
combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | Experimental | combination of erector spinae plane block (ESPB) and interscalene block(IB).the ESPB will be performed using linear ultrasound transducer (Philips® cx 50 extreme edition, USA) and we will inject 20 ml solution(10 ml 0.5% bupivacaine, 5 ml 2% lidocaine, and 5 ml normal saline). the IB will be performed using the same ultrasound machine and injecting the same solution Receives: Other: regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the regional blocks
completion of the surgery without need of general anesthesia.
Measured: from the start to the end of the operation
Secondary outcomes (3)
duration of the blocks
Time to first request of rescue analgesia postoperative
Measured: 24- hours in the postoperative period
Patients' satisfaction
degree of patients' satisfaction
Measured: 24-hours postoperative
Any adverse events
postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence
Measured: 24-hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Mohamed Elsayed Afandy
- Responsible party
- Principal investigator, Mona Raafat Elghamry, Tanta University
- Investigators
- Mona R Elghamry, MD, Principal investigator, Tanta University, Faculty of MedicineMohamed E Afandy, MD, Study director, Tanta University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239716
- Sponsor's protocol ID
- mastectomy regional anesthesia
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: statistics of the age ,BMI, duration of surgery,success rate, time of first analgesic request,patients' and surgeon's satisfaction, and complications
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Combined Ultrasound Guided Interscalene Brachial Plexus Block and Erector Spinae Plane Block for Anesthesia in Modified Radical Mastectomy With Axillary Lymph Node Dissection: Pilot Study
- ClinicalTrials.gov ID
- NCT04239716
- Acronym / sponsor ID
- mastectomy regional anesthesia
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Dr. Mohamed Elsayed Afandy
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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.
local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.
Detailed description
inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | Experimental | Other: regional anesthesiacombination of erector spinae plane block (ESPB) and interscalene block(IB).the ESPB will be performed using linear ultrasound transducer (Philips® cx 50 extreme edition, USA) and we will inject 20 ml solution(10 ml 0.5% bupivacaine, 5 ml 2% lidocaine, and 5 ml normal saline). the IB will be performed using the same ultrasound machine and injecting the same solution |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 40-85 years old
- American Society of Anesthesiologists' physical status III and IV
- Planned for modified radical mastectomy with axillary lymph node dissection
Key exclusion criteria (8 listed)
- Patient refusal
- Neurological or psychiatric disorders
- Local infection at injection site
- Spine or chest wall deformity
- Allergy or any contraindication to any of the study drugs
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 |
|---|---|---|
| regional anesthesiacombination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection | Other | regional anesthesia |
Primary outcome
Success rate of the regional blocks
Time frame: from the start to the end of the operation
completion of the surgery without need of general anesthesia.
3 secondary outcomes
duration of the blocks
Time frame: 24- hours in the postoperative period
Patients' satisfaction
Time frame: 24-hours postoperative
Any adverse events
Time frame: 24-hours postoperative
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 30 Nov 2023.
- Individual participant dataSharing planned: Yes. statistics of the age ,BMI, duration of surgery,success rate, time of first analgesic request,patients' and surgeon's satisfaction, and complications
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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.
Mona R Elghamry, MD principal investigator
Tanta University, Faculty of Medicine
Mohamed E Afandy, MD study director
Tanta University, 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 Phase 3 study testing regional anesthesia in people with Breast Cancer, run by Tanta University 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 3 inclusion and 8 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 30 Nov 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success rate of the regional blocks (time frame: from the start to the end of the operation). 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 30 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.