Breast Cancer Patients
Conditions
Brief summary
To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia & stress response in patient undergoing modified radical mastectomy.
Detailed description
60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.
Interventions
DRUGDexmedetomidine
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
DRUGplacebo
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
Sponsors
South Egypt Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA I - II patients * weight 50- 100 kg)
Exclusion criteria
* a history of bleeding diathesis, * relevant drug allergy * opioid dependence, * sepsis, * those with psychiatric illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine consumption mg/day | 48 HOURS | by Patient-controlled analgesia (PCA) device |
| Visual Analog Scale (VAS), scored from 0-10 | 48 hours | pain measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| first request of analgesia | 48 hours | time of the first request of analgesia postoperative if the VAS ≥ 3 |
| level of stress hormones | 48 hours | cortisol level |
| Adverse Events | 48 hours | Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea,Vomiting,Arrhythmia.Hypotension,Pneumothorax,Vascular injury andItching |
Countries
Egypt
Contacts
Primary Contactmohamad F mohamad, MD
Outcome results
None listed