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Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients

Phase 3
Conditions
Breast Cancer Patients
Interventions
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
Inclusion Criteria
  • ASA I - II patients
  • weight 50- 100 kg)
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Exclusion Criteria
  • a history of bleeding diathesis,
  • relevant drug allergy
  • opioid dependence,
  • sepsis,
  • those with psychiatric illnesses
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
controlplacebopreoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
dexmetedomedineDexmedetomidinepreoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
Primary Outcome Measures
NameTimeMethod
morphine consumption mg/day48 HOURS

by Patient-controlled analgesia (PCA) device

Visual Analog Scale (VAS), scored from 0-1048 hours

pain measurement

Secondary Outcome Measures
NameTimeMethod
first request of analgesia48 hours

time of the first request of analgesia postoperative if the VAS ≥ 3

level of stress hormones48 hours

cortisol level

Adverse Events48 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

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