Stellate Ganglion Block for Prevention of Post Mastectomy... | NCT06263907

Studies
Stellate Ganglion Block for Prevention of Post Mastectomy Depression

NCT06263907

Sponsor

Mansoura University

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Mastectomy
Pain, Acute
Pain, Chronic

Interventions

Stellate gangalion block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Dec 30, 2028Estimated

First Submitted Date

Feb 5, 2024

First Submission Date that Met QC Criteria

Feb 9, 2024

First Posted Date

Feb 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2026

Last Update Posted Date

Feb 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

maha abou-zeid, Assistant Professor of Anaesthesia and Surgical Intensive Care, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: Stellate gangalion block
Control group (Group C)	No Intervention	Patients will not receive stellate gangalion block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stellate gangalion block	Procedure	The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
incidence of postmastectomy depression	Beck Depression Inventory (BDI) score	3 months postoperatively
the need for postoperative antidepressant	needed or not

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female patients scheduled to do unilateral modified radical mastectomy

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maha Abo-Zeid, MD	Contact	01019216192		mahazed@mans.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maha	Recruiting	Al Mansurah			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

Masking

Double

Masking Description

The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection.

Who Masked

ParticipantInvestigator