Breast CancerPhase 2NCT07081581
Analgesic Effect of Serratus Plane Block With Adjuvant Agents in Breast Cancer Surgery
A Phase 2 study testing Bupivacain, Bupivacaine and Magnesium sulfate and Bupivacaine and Dexmedetomidine ile Blokaj in people with Breast Cancer and Post Operative Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Breast Cancer, Post Operative Pain
- What is being tested?
- Bupivacain, Bupivacaine and Magnesium sulfate and Bupivacaine and Dexmedetomidine ile Blokaj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Mar 2023
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Less than 30 years of age, older than 70 years of age or ASA (American Society of Anaesthesiologists) Classification IV,
- Receiving antithrombotic therapy with abnormal coagulation parameters,
- Infection or anatomical abnormality at the blockage site,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Üsküdar, 34674
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Serratus Plane Block With Different Adjuvant Agents in Breast Cancer Surgery
Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. The aim of this study was to investigate the effect of magnesium and dexmedetomidine as adjuvant agents on postoperative analgesia in serratus anterior plane block in patients undergoing modified radical mastectomy.
Read the detailed description
In this prospective, double-blind, randomised controlled study, a total of 75 patients aged 30-70 years, who were planned for elective modified radical mastectomy after ethics committee approval, were included. Patients were randomly divided into three groups. After induction of general anaesthesia, serratus anterior plane block was applied to all patients. Group B received bupivacaine 30 ml (0.25%), Group D received bupivacaine 30 ml (0.25%) + dexmedetomidine 1μg/kg, Group M received bupivacaine 30 ml (0.25%) + 500 mg magnesium sulphate. Haemodynamic parameters, numerical rating scale (NRS) scores, number of tramadol use with patient-controlled analgesia device, additional analgesic drug consumption and side effects were recorded at 2, 6, 12 and 24 hours postoperatively.
- Conditions
- Breast Cancer, Post Operative Pain
- Being tested
- Bupivacain, Bupivacaine and Magnesium sulfate, Bupivacaine and Dexmedetomidine ile Blokaj
- Keywords
- pain management, serratus anterior plane block, Breast cancer surgery
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Control group
In Group B( control group), bupivacaine was given as additional medication in the serratus block application.
Bupivacaine and Magnesium sulfateDrug
Also called Local anesthetic with added adjuvant agent(1)
In Group M, bupivacaine and magnesium were given as additional medication in the serratus block application.
Bupivacaine and Dexmedetomidine ile BlokajDrug
Also called Local anesthetic with added adjuvant agent(2)
In Group D, bupivacaine and dexmedetomidine were given as additional medication in the serratus block application.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Group B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%) Receives: Drug: Bupivacain |
| Group M | Experimental | Group M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate Receives: Drug: Bupivacaine and Magnesium sulfate |
| Group D | Experimental | Group D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine. Receives: Drug: Bupivacaine and Dexmedetomidine ile Blokaj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic efficacy
Hemodynamic parameters (heart rate, noninvasive mean arterial blood pressure, peripheral oxygen saturation), numerical rating scale (NRS) scores, number of tramadol uses with patient-controlled analgesia device, and additional analgesic drug consumption were recorded at 2, 6, 12, and 24 hours after surgery. The Numerical Rating Scale (NRS) is a subjective scale in which patients rate their pain intensity by selecting a number between 0 and 10. 0 means "no pain," while 10 means "worst pain imaginable." Patients typically rate their pain over the past 24 hours. It can be used in both verbal and written formats.
Measured: until the 24th hour postoperatively
Secondary outcomes (1)
Complications due to adjuvant agents
Complications due to adjuvant agents used in serratus plan blockade
Measured: until the 24th hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Aug 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After induction of general anaesthesia, serratus anterior plane block was performed in all patients. Group B received bupivacaine (control group), Group D received bupivacaine + dexmedetomidine, Group M received bupivacaine + magnesium sulphate.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Dilek MD Metin Yamac, Principal investigator, Sultan Abdülhamid Han education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081581
- Sponsor's protocol ID
- SBU-ANESTEZİ-DMY-03
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Serratus Plane Block With Different Adjuvant Agents in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07081581
- Acronym / sponsor ID
- SBU-ANESTEZİ-DMY-03
- Conditions
- Breast Cancer, Post Operative Pain
- Keywords
- pain management, serratus anterior plane block, Breast cancer surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Jul 2025 (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.
Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. The aim of this study was to investigate the effect of magnesium and dexmedetomidine as adjuvant agents on postoperative analgesia in serratus anterior plane block in patients undergoing modified radical mastectomy.
Detailed description
In this prospective, double-blind, randomised controlled study, a total of 75 patients aged 30-70 years, who were planned for elective modified radical mastectomy after ethics committee approval, were included. Patients were randomly divided into three groups. After induction of general anaesthesia, serratus anterior plane block was applied to all patients. Group B received bupivacaine 30 ml (0.25%), Group D received bupivacaine 30 ml (0.25%) + dexmedetomidine 1μg/kg, Group M received bupivacaine 30 ml (0.25%) + 500 mg magnesium sulphate. Haemodynamic parameters, numerical rating scale (NRS) scores, number of tramadol use with patient-controlled analgesia device, additional analgesic drug consumption and side effects were recorded at 2, 6, 12 and 24 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- After induction of general anaesthesia, serratus anterior plane block was performed in all patients. Group B received bupivacaine (control group), Group D received bupivacaine + dexmedetomidine, Group M received bupivacaine + magnesium sulphate.
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Drug: BupivacainGroup B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%) |
| Group M | Experimental | Drug: Bupivacaine and Magnesium sulfateGroup M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate |
| Group D | Experimental | Drug: Bupivacaine and Dexmedetomidine ile BlokajGroup D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Less than 30 years of age, older than 70 years of age or ASA (American Society of Anaesthesiologists) Classification IV,
- Receiving antithrombotic therapy with abnormal coagulation parameters,
- Infection or anatomical abnormality at the blockage site,
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 |
|---|---|---|
| BupivacainAlso: Control groupIn Group B( control group), bupivacaine was given as additional medication in the serratus block application. | Drug | Group B |
| Bupivacaine and Magnesium sulfateAlso: Local anesthetic with added adjuvant agent(1)In Group M, bupivacaine and magnesium were given as additional medication in the serratus block application. | Drug | Group M |
| Bupivacaine and Dexmedetomidine ile BlokajAlso: Local anesthetic with added adjuvant agent(2)In Group D, bupivacaine and dexmedetomidine were given as additional medication in the serratus block application. | Drug | Group D |
Primary outcome
Postoperative analgesic efficacy
Time frame: until the 24th hour postoperatively
Hemodynamic parameters (heart rate, noninvasive mean arterial blood pressure, peripheral oxygen saturation), numerical rating scale (NRS) scores, number of tramadol uses with patient-controlled analgesia device, and additional analgesic drug consumption were recorded at 2, 6, 12, and 24 hours after surgery. The Numerical Rating Scale (NRS) is a subjective scale in which patients rate their pain intensity by selecting a number between 0 and 10. 0 means "no pain," while 10 means "worst pain imaginable." Patients typically rate their pain over the past 24 hours. It can be used in both verbal and written formats.
1 secondary outcome
Complications due to adjuvant agents
Time frame: until the 24th hour postoperatively
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 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Dilek MD Metin Yamac principal investigator
Sultan Abdülhamid Han education and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacain, Bupivacaine and Magnesium sulfate and Bupivacaine and Dexmedetomidine ile Blokaj in people with Breast Cancer and Post Operative Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 0 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 23 Jul 2025. 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 Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative analgesic efficacy (time frame: until the 24th hour postoperatively). 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 23 Jul 2025.