Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-12-30

Brief Summary

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Complications after mastectomy include chronic pain and depression.

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Detailed Description

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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.

Conditions

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Mastectomy Pain, Acute Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection.

Study Groups

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Stellate gangalion block group (Group S)

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

Group Type EXPERIMENTAL

Stellate gangalion block

Intervention Type PROCEDURE

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

Control group (Group C)

Patients will not receive stellate gangalion block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stellate gangalion block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No