AnalgesiaNCT05361837
Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery
A study testing Single level serratus anterior plane block, Single level serratus anterior plane block with dexmedetomidine and Bilevel serratus anterior plane block in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Single level serratus anterior plane block, Single level serratus anterior plane block with dexmedetomidine and Bilevel serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for modified radical mastectomy,
- Age 18-65 years,
- ASA I-II
Who cannot join
- patient refusal,
- coagulation defects,
- abnormal kidney or liver functions,
- local infection at site of injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Walaa Y Elsabeeny
Cairo, Cairo Governorate, 11796
Walaa Y Elsabeeny, MD, +201007798466, walaa.elsabeeny@nci.cu.edu.eg
About this study
Official title: Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery
This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.
- Conditions
- Analgesia
- Being tested
- Single level serratus anterior plane block, Single level serratus anterior plane block with dexmedetomidine, Bilevel serratus anterior plane block, Bilevel serratus anterior plane block with dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single level serratus anterior plane blockProcedure or surgery
Serratus anterior plane block with local anesthetics at the third rib
Single level serratus anterior plane block with dexmedetomidineProcedure or surgery
Serratus anterior plane block with local anesthetics and dexmedetomidine at the third rib
Bilevel serratus anterior plane blockProcedure or surgery
Serratus anterior plane block with local anesthetics at the third and fifth rib
Bilevel serratus anterior plane block with dexmedetomidineProcedure or surgery
Serratus anterior plane block with local anesthetics and dexmedetomidine at the third and fifth rib
| Study group | Role | What they receive |
|---|---|---|
| Single level serratus anterior plane block | Active comparator | the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only Receives: Procedure: Single level serratus anterior plane block |
| Single level serratus anterior plane block with dexmedetomidine | Experimental | the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine Receives: Procedure: Single level serratus anterior plane block with dexmedetomidine |
| Bilevel serratus anterior plane block | Experimental | the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only Receives: Procedure: Bilevel serratus anterior plane block |
| Bilevel serratus anterior plane block with dexmedetomidine | Experimental | the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine Receives: Procedure: Bilevel serratus anterior plane block with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to receive analgesia
first time to receive morphine analgesia in hours
Measured: First 24 hours postoperatively
Total analgesic requisite
total amount of morphine consumption in the first 24 hours postoperatively in mg
Measured: First 24 hours postoperatively
Secondary outcomes (4)
Pain scores
pain scores will be assessed using Visual Analogue Scale on a sale from 0 to 10 with 0 meanung no pain and 10 meaning severe pain
Measured: First 24 hours postoperatively
Side effects
nausea and vomiting and hematoma at site of injection
Measured: First 24 hours postoperatively
Perioperative heart rate values
heart rate values in the form of beat per minute in the perioperative period including preoperative, intraoperative and postoperative
Measured: First 24 hours
Mean arterial blood pressure
Mean arterial blood pressure values in the form mmHg in the perioperative period including preoperative, intraoperative and postoperative
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start10 May 2022
- Primary completion15 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Assistant Professor of Anesthesia and Pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361837
- Sponsor's protocol ID
- AP2204-50104
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05361837
- Acronym / sponsor ID
- AP2204-50104
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 5 May 2022 (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.
This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single level serratus anterior plane block | Active comparator | Procedure: Single level serratus anterior plane blockthe allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only |
| Single level serratus anterior plane block with dexmedetomidine | Experimental | Procedure: Single level serratus anterior plane block with dexmedetomidinethe allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine |
| Bilevel serratus anterior plane block | Experimental | Procedure: Bilevel serratus anterior plane blockthe allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only |
| Bilevel serratus anterior plane block with dexmedetomidine | Experimental | Procedure: Bilevel serratus anterior plane block with dexmedetomidinethe allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for modified radical mastectomy,
- Age 18-65 years,
- ASA I-II
Key exclusion criteria (4 listed)
- patient refusal,
- coagulation defects,
- abnormal kidney or liver functions,
- local infection at site of injection.
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 |
|---|---|---|
| Single level serratus anterior plane blockSerratus anterior plane block with local anesthetics at the third rib | Procedure or surgery | Single level serratus anterior plane block |
| Single level serratus anterior plane block with dexmedetomidineSerratus anterior plane block with local anesthetics and dexmedetomidine at the third rib | Procedure or surgery | Single level serratus anterior plane block with dexmedetomidine |
| Bilevel serratus anterior plane blockSerratus anterior plane block with local anesthetics at the third and fifth rib | Procedure or surgery | Bilevel serratus anterior plane block |
| Bilevel serratus anterior plane block with dexmedetomidineSerratus anterior plane block with local anesthetics and dexmedetomidine at the third and fifth rib | Procedure or surgery | Bilevel serratus anterior plane block with dexmedetomidine |
Primary outcome
First time to receive analgesia
Time frame: First 24 hours postoperatively
first time to receive morphine analgesia in hours
Total analgesic requisite
Time frame: First 24 hours postoperatively
total amount of morphine consumption in the first 24 hours postoperatively in mg
4 secondary outcomes
Pain scores
Time frame: First 24 hours postoperatively
Side effects
Time frame: First 24 hours postoperatively
Perioperative heart rate values
Time frame: First 24 hours
Mean arterial blood pressure
Time frame: First 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Walaa Y Elsabeeny, MD principal investigator
Assistant Professor of Anesthesia and Pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single level serratus anterior plane block, Single level serratus anterior plane block with dexmedetomidine and Bilevel serratus anterior plane block in people with Analgesia, run by National Cancer Institute, Egypt 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 4 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walaa Y Elsabeeny, MD (201007798466 ext. +2, walaa.elsabeeny@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First time to receive analgesia (time frame: First 24 hours postoperatively). The study lists 2 primary outcomes in all. 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 Jun 2026.