Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Pain, Acute Clinical Trial

— SGB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263907
• Other study ID #: stellate ganglion block
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: Maha Abo-Zeid, MD
• Phone: 01019216192
• Email: mahazed[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complications after mastectomy include chronic pain and depression.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Mastectomy
• Pain, Acute
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
Egypt	Maha	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postmastectomy depression	Beck Depression Inventory (BDI) score	6 months postoperatively
Secondary	incidence of postmastectomy depression	Beck Depression Inventory (BDI) score	3 months postoperatively
Secondary	the need for postoperative antidepressant	needed or not	during the first 6 months postoperatively
Secondary	acute postoperative pain at the incision site (breast and the axilla)	Numerical rating scale (NRS) (0-10)	every 12 hour for the first 48 hour recorded
Secondary	chronic postmastectomy pain at the incision site	Numerical rating scale (NRS) (0-10)	at 3 and 6 months postoperatively
Secondary	incidence of nausea and vomiting	occurred or not	during first 3 postoperative days
Secondary	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	during the first 6 months postoperatively
Secondary	Any complications related to stellate ganglion injection	local hematoma, persistent postoperative horner's syndrome or respiratory distress	within 1 day postoperatively