MastectomySGBNCT06263907
Stellate Ganglion Block for Prevention of Post Mastectomy Depression
A study testing Stellate gangalion block in people with Mastectomy and Pain, Acute, run by Mansoura University at 1 site in Egypt.
Trial summary
Complications after mastectomy include chronic pain and depression. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Mastectomy, Pain, Acute, Pain, Chronic
- What is being tested?
- Stellate gangalion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Dec 2028
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Age ranging from 18 to 65 years
- American Society of Anesthesiologists (ASA) no more than II
- Had unilateral cancer breast
- Scheduled to do unilateral modified radical mastectomy
Who cannot join
- Pregnant female
- Existing Horner syndrome
- Had any neuromuscular disease
- Had allergy to local anesthetics
- History of use of analgesics
- Had any deformity or a previous surgery in the neck or ipsilateral arm or breast
Show all 10Show fewer
- Had any contraindication to the procedure (coagulation disorders, local infection, sepsis)
- Had any contraindication to the sympathetic blockade (decompensate cardiopulmonary or hemodynamic disorders)
- History of psychotic disorder including depression, bipolar disorder or personality disorder
- Patient with Beck Depression Inventory (BDI) score more than 13
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Complications after mastectomy include chronic pain and depression.
Read the detailed description
A mastectomy is surgery could be associated with complications include chronic pain and depression. In female breast cancer patients, the incidence of postoperative depression was 46.55%. Stellate ganglion block had been used for treating post-traumatic stress disorder (PTSD) and depression symptoms even in its prevention. Also, it used in treatment of chronic pain.
- Conditions
- Mastectomy, Pain, Acute, Pain, Chronic
- Being tested
- Stellate gangalion block
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate gangalion blockProcedure or surgery
The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block
| Study group | Role | What they receive |
|---|---|---|
| Stellate gangalion block group (Group S) | Experimental | Patients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml Receives: Procedure: Stellate gangalion block |
| Control group (Group C) | No intervention | Patients will not receive stellate gangalion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postmastectomy depression
Beck Depression Inventory (BDI) score
Measured: 6 months postoperatively
Secondary outcomes (7)
incidence of postmastectomy depression
Beck Depression Inventory (BDI) score
Measured: 3 months postoperatively
the need for postoperative antidepressant
needed or not
Measured: during the first 6 months postoperatively
acute postoperative pain at the incision site (breast and the axilla)
Numerical rating scale (NRS) (0-10)
Measured: every 12 hour for the first 48 hour recorded
chronic postmastectomy pain at the incision site
Numerical rating scale (NRS) (0-10)
Measured: at 3 and 6 months postoperatively
incidence of nausea and vomiting
occurred or not
Measured: during first 3 postoperative days
Functional pain in the ipsilateral shoulder
extended from the shoulder to the elbow or to the hand either associated with swelling, changing in the colour or temperature of that limb or associated with reduction in the range of the movement (elbow extension or arm abduction or fixed flexion deformity
Measured: during the first 6 months postoperatively
Any complications related to stellate ganglion injection
local hematoma, persistent postoperative horner's syndrome or respiratory distress
Measured: within 1 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263907
- Sponsor's protocol ID
- stellate ganglion block
- Acronym
- SGB
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression
- ClinicalTrials.gov ID
- NCT06263907
- Acronym / sponsor ID
- SGB / stellate ganglion block
- Conditions
- Mastectomy, Pain, Acute, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Feb 2024 (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.
Complications after mastectomy include chronic pain and depression.
Detailed description
A mastectomy is surgery could be associated with complications include chronic pain and depression. In female breast cancer patients, the incidence of postoperative depression was 46.55%. Stellate ganglion block had been used for treating post-traumatic stress disorder (PTSD) and depression symptoms even in its prevention. Also, it used in treatment of chronic pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block.
| Arm | Type | Receives |
|---|---|---|
| Stellate gangalion block group (Group S) | Experimental | Procedure: Stellate gangalion blockPatients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml |
| Control group (Group C) | No intervention | –Patients will not receive stellate gangalion block |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients
- Age ranging from 18 to 65 years
- American Society of Anesthesiologists (ASA) no more than II
- Had unilateral cancer breast
- Scheduled to do unilateral modified radical mastectomy
Key exclusion criteria (10 listed)
- Pregnant female
- Existing Horner syndrome
- Had any neuromuscular disease
- Had allergy to local anesthetics
- History of use of analgesics
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 |
|---|---|---|
| Stellate gangalion blockThe efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block | Procedure or surgery | Stellate gangalion block group (Group S) |
Primary outcome
incidence of postmastectomy depression
Time frame: 6 months postoperatively
Beck Depression Inventory (BDI) score
7 secondary outcomes
incidence of postmastectomy depression
Time frame: 3 months postoperatively
the need for postoperative antidepressant
Time frame: during the first 6 months postoperatively
acute postoperative pain at the incision site (breast and the axilla)
Time frame: every 12 hour for the first 48 hour recorded
chronic postmastectomy pain at the incision site
Time frame: at 3 and 6 months postoperatively
incidence of nausea and vomiting
Time frame: during first 3 postoperative days
Functional pain in the ipsilateral shoulder
Time frame: during the first 6 months postoperatively
Any complications related to stellate ganglion injection
Time frame: within 1 day postoperatively
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 17 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate gangalion block in people with Mastectomy and Pain, Acute, run by Mansoura 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 5 inclusion and 10 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 17 Feb 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 Maha Abo-Zeid, MD (01019216192, mahazed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postmastectomy depression (time frame: 6 months 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 17 Feb 2026.