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NCT Number: NCT06263907

Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Complications after mastectomy include chronic pain and depression.

Recruiting

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Key information

Conditions

Mastectomy Acute Pain Chronic Pain Neurologic Manifestations Pain Pain, Acute Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maha

Al Mansurah, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stellate gangalion block

Procedure

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

Primary outcomes

  1. incidence of postmastectomy depression

    Time frame: 6 months postoperatively

    Beck Depression Inventory (BDI) score

Secondary outcomes

  1. incidence of postmastectomy depression

    Time frame: 3 months postoperatively

    Beck Depression Inventory (BDI) score

  2. the need for postoperative antidepressant

    Time frame: during the first 6 months postoperatively

    needed or not

  3. 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)

  4. chronic postmastectomy pain at the incision site

    Time frame: at 3 and 6 months postoperatively

    Numerical rating scale (NRS) (0-10)

  5. incidence of nausea and vomiting

    Time frame: during first 3 postoperative days

    occurred or not

  6. 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

  7. Any complications related to stellate ganglion injection

    Time frame: within 1 day postoperatively

    local hematoma, persistent postoperative horner's syndrome or respiratory distress

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Abo-Zeid, MD

CONTACT

[email protected]

01019216192

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: SGB

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 16, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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