Stellate Ganglion Block for Prevention of Post Mastectomy Depression

NCT06263907 | Recruiting

• 1 other identifier: stellate ganglion block
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Complications after mastectomy include chronic pain and depression.

Conditions

Mastectomy; Pain, Acute; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• incidence of postmastectomy depression

  Beck Depression Inventory (BDI) score

  6 months postoperatively

Secondary Outcomes (7)

• incidence of postmastectomy depression

  3 months postoperatively

• the need for postoperative antidepressant

  during the first 6 months postoperatively

• acute postoperative pain at the incision site (breast and the axilla)

  every 12 hour for the first 48 hour recorded

• chronic postmastectomy pain at the incision site

  at 3 and 6 months postoperatively

• incidence of nausea and vomiting

  during first 3 postoperative days

Study Arms (2)

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

Stellate gangalion block PROCEDURE

The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block

Stellate gangalion block group (Group S)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Female patients scheduled to do unilateral modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Maha

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maha Abo-Zeid, MD

CONTACT

01019216192; mahazed@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesia and Surgical Intensive Care

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)