Back to resultsDexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
Primary Purpose
Femoral Fractures
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Fractures focused on measuring Femoral Fractures
Eligibility Criteria
Inclusion Criteria:
- Adults with femural fracture
Exclusion Criteria:
- Hypersensitivity to drugs
- Neurological diseases
- Coagulation abnormalities
- Infection at the site of block
Sites / Locations
- Shahid Mohammadi hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bupivacaine
Dexmedetomidine and bupivacaine
Arm Description
30cc of 0.25% bupivacaine
30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine
Outcomes
Primary Outcome Measures
Pain
A point between 0 and 10 based on patient report
Secondary Outcome Measures
Respiratory depression
respiratory rate < 12/min
Hypotension
Systolic blood pressure < 90 mmHg
Baradycardia
Heart rate < 60/min
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658760
Brief Title
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
Official Title
Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hamidreza Mahboobi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures
Keywords
Femoral Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
30cc of 0.25% bupivacaine
Arm Title
Dexmedetomidine and bupivacaine
Arm Type
Active Comparator
Arm Description
30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine plus placebo
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
dexmedetomidine and Bupivacaine
Primary Outcome Measure Information:
Title
Pain
Description
A point between 0 and 10 based on patient report
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Respiratory depression
Description
respiratory rate < 12/min
Time Frame
24 hours
Title
Hypotension
Description
Systolic blood pressure < 90 mmHg
Time Frame
24 hours
Title
Baradycardia
Description
Heart rate < 60/min
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with femural fracture
Exclusion Criteria:
Hypersensitivity to drugs
Neurological diseases
Coagulation abnormalities
Infection at the site of block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamidreza Mahboobi
Phone
9172121995
Ext
+98
Email
hamidrezamahboobi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Abdi
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Mohammadi hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79176
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi
Phone
09809364300250
Email
hamidrezamahboobi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
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