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Stellate Ganglion Block for Prevention of Post Mastectomy Depression (SGB)

M

Mansoura University

Status

Enrolling

Conditions

Mastectomy
Pain, Acute
Pain, Chronic

Treatments

Procedure: Stellate gangalion block

Study type

Interventional

Funder types

Other

Identifiers

NCT06263907
stellate ganglion block

Details and patient eligibility

About

Complications after mastectomy include chronic pain and depression.

Full 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.

Enrollment

140 estimated patients

Sex

Female

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Stellate gangalion block group (Group S)
Experimental group
Description:
Patients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml
Treatment:
Procedure: Stellate gangalion block
Control group (Group C)
No Intervention group
Description:
Patients will not receive stellate gangalion block

Trial contacts and locations

1

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Central trial contact

Maha Abo-Zeid, MD

Data sourced from clinicaltrials.gov

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