Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Mansoura University140 enrolled

Overview

Complications after mastectomy include chronic pain and depression.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

140

Conditions

Mastectomy Pain, Acute Pain, Chronic

Interventions

Stellate gangalion blockPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Maha

Al Mansurah, Egypt

RECRUITING

Outcomes

Primary Outcomes

incidence of postmastectomy depression

Beck Depression Inventory (BDI) score

Time frame: 6 months postoperatively

Secondary Outcomes

incidence of postmastectomy depression

Beck Depression Inventory (BDI) score

Time frame: 3 months postoperatively

the need for postoperative antidepressant

needed or not

Time frame: during the first 6 months postoperatively

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

Numerical rating scale (NRS) (0-10)

Time frame: every 12 hour for the first 48 hour recorded

chronic postmastectomy pain at the incision site

Numerical rating scale (NRS) (0-10)

Time frame: at 3 and 6 months postoperatively

incidence of nausea and vomiting

occurred or not

Time frame: during first 3 postoperative days

Functional pain in the ipsilateral shoulder

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

Time frame: during the first 6 months postoperatively

Any complications related to stellate ganglion injection

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

Central Contacts

Maha Abo-Zeid, MD

CONTACT

01019216192 mahazed@mans.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.