Stellate Ganglion Block for Prevention of Post Mastectomy Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stellate gangalion block.
- Who it may be relevant to
- Registry conditions: Mastectomy, Pain, Acute, Pain, Chronic. Basic parameters: 21 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Overview
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.
Interventions
- Procedure Stellate gangalion block
The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block
Primary outcome measures
- incidence of postmastectomy depression [Time frame: 6 months postoperatively]
Secondary outcome measures (7)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Maha — Al Mansurah
Identifiers
NCT: NCT06263907 · stellate ganglion block