Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedStudy Start
First participant enrolled
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2017
CompletedFebruary 27, 2017
February 1, 2017
2 months
February 2, 2017
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
morphine consumption mg/day
by Patient-controlled analgesia (PCA) device
48 HOURS
Visual Analog Scale (VAS), scored from 0-10
pain measurement
48 hours
Secondary Outcomes (3)
first request of analgesia
48 hours
level of stress hormones
48 hours
Adverse Events
48 hours
Study Arms (2)
dexmetedomedine
ACTIVE COMPARATORpreoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
control
PLACEBO COMPARATORpreoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
Interventions
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
Eligibility Criteria
You may qualify if:
- ASA I - II patients
- weight 50- 100 kg)
You may not qualify if:
- a history of bleeding diathesis,
- relevant drug allergy
- opioid dependence,
- sepsis,
- those with psychiatric illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
Asyut, 171516, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mohamad F mohamad, MD
Assiut University
- STUDY DIRECTOR
Saher mohamad, MD
Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia,ICU and pain relief
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 8, 2017
Study Start
February 2, 2017
Primary Completion
April 2, 2017
Study Completion
April 2, 2017
Last Updated
February 27, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share