Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients
- Registration Number
- NCT03046238
- Lead Sponsor
- South Egypt Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- ASA I - II patients
- weight 50- 100 kg)
- a history of bleeding diathesis,
- relevant drug allergy
- opioid dependence,
- sepsis,
- those with psychiatric illnesses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control placebo preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine dexmetedomedine Dexmedetomidine preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
🇪🇬Assuit, Egypt