Stellate Ganglion Block for Prevention of Post Mastectomy Depression (SGB)

February 15, 2026 updated by: maha abou-zeid, Mansoura University

Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Complications after mastectomy include chronic pain and depression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Recruiting
        • Maha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate gangalion block group (Group S)
Patients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml
Procedure: Stellate gangalion block
The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block
No Intervention: Control group (Group C)
Patients will not receive stellate gangalion block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postmastectomy depression
Time Frame: 6 months postoperatively
Beck Depression Inventory (BDI) score
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postmastectomy depression
Time Frame: 3 months postoperatively
Beck Depression Inventory (BDI) score
3 months postoperatively
the need for postoperative antidepressant
Time Frame: during the first 6 months postoperatively
needed or not
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
Numerical rating scale (NRS) (0-10)
every 12 hour for the first 48 hour recorded
chronic postmastectomy pain at the incision site
Time Frame: at 3 and 6 months postoperatively
Numerical rating scale (NRS) (0-10)
at 3 and 6 months postoperatively
incidence of nausea and vomiting
Time Frame: during first 3 postoperative days
occurred or not
during first 3 postoperative days
Functional pain in the ipsilateral shoulder
Time Frame: during the first 6 months postoperatively
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
during the first 6 months postoperatively
Any complications related to stellate ganglion injection
Time Frame: within 1 day postoperatively
local hematoma, persistent postoperative horner's syndrome or respiratory distress
within 1 day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • stellate ganglion block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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