Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorMansoura University
About this trial
Complications after mastectomy include chronic pain and depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients
Age ranging from 18 to 65 years
American Society of Anesthesiologists (ASA) no more than II
Had unilateral cancer breast
Disqualifiers
Pregnant female
Existing Horner syndrome
Had any neuromuscular disease
Had allergy to local anesthetics
Trial design
Design model
Parallel
Treatments tested in this trial
Stellate gangalion block
Procedure/SurgeryThe efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Stellate gangalion block group (Group S)Experimental treatment 1 intervention
Group B: Control group (Group C)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
incidence of postmastectomy depression
Beck Depression Inventory (BDI) score
Time frame
6 months postoperativelySecondary outcomes
1
incidence of postmastectomy depression
Beck Depression Inventory (BDI) score
Time frame
3 months postoperatively2
the need for postoperative antidepressant
needed or not
Time frame
during the first 6 months postoperatively3
acute postoperative pain at the incision site (breast and the axilla)
Numerical rating scale (NRS) (0-10)
Time frame
every 12 hour for the first 48 hour recorded4
chronic postmastectomy pain at the incision site
Numerical rating scale (NRS) (0-10)
Time frame
at 3 and 6 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov