Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Not Applicable

Recruiting

• Conditions: Mastectomy; Pain, Acute; Pain, Chronic
• Interventions: Procedure: Stellate gangalion block

• Registration Number: NCT06263907
• Lead Sponsor: Mansoura University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-16
• Study Start: 2024-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate gangalion block group (Group S)	Stellate gangalion block	Patients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml

Primary Outcome Measures

Name	Time	Method
incidence of postmastectomy depression	6 months postoperatively	Beck Depression Inventory (BDI) score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maha; 🇪🇬 Mansoura, Egypt