Mastectomy, Pain, Acute, Pain, Chronic
Conditions
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.
Interventions
PROCEDUREStellate gangalion block
The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postmastectomy depression | 6 months postoperatively | Beck Depression Inventory (BDI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| chronic postmastectomy pain at the incision site | at 3 and 6 months postoperatively | Numerical rating scale (NRS) (0-10) |
| 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 |
| Any complications related to stellate ganglion injection | within 1 day postoperatively | local hematoma, persistent postoperative horner's syndrome or respiratory distress |
Countries
Egypt
Contacts
CONTACTMaha Abo-Zeid, MD
Outcome results
None listed